Bio-Rad
Medical device manufacturer in 92430 Marnes-La-Coquette, FR.
319510(k) clearances
1PMA approvals
0recalls
Device types
- JJY Multi-Analyte Controls, All Kinds (Assayed) 61
- DIF Drug Mixture Control Materials 31
- JJX Single (Specified) Analyte Controls… 21
- LCP Assay, Glycosylated Hemoglobin 15
- DHN Antinuclear Antibody, Indirect… 14
- JJS Controls For Blood-Gases, (Assayed And… 9
- LKJ Antinuclear Antibody, Antigen, Control 9
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 9
- GGN Plasma, Coagulation Control 7
- JJT Enzyme Controls (Assayed And Unassayed) 6
- JSO Culture Media, Antimicrobial Susceptibility… 6
- JJW Urinalysis Controls (Assayed And Unassayed) 5
- HKX Tonometer, Ac-Powered 5
- CGN Acid, Folic, Radioimmunoassay 5
- CGI Radioimmunoassay, Estriol 4
- CDX Radioimmunoassay, Total Thyroxine 4
- JPD Hemoglobin A2 Quantitation 4
- CDD Radioassay, Vitamin B12 3
- DHR System, Test, Rheumatoid Factor 3
- CDF Acid, Vanilmandelic, Diazo, P-Nitroaniline/V… 3
510(k) clearances (latest 300)
| 510(k) | Device | Decision |
|---|---|---|
| K171061 | MRSASelect IIJSO · Traditional | 12/28/2017SE |
| K122187 | Vreselect Culture MediumJSO · Traditional | 11/06/2012SE |
| K103684 | Vreselect Culture MediumJSO · Traditional | 10/21/2011SE |
| K093678 | Platelia Aspergillus Eia Model 62793NOM · Traditional | 01/13/2011SE |
| K100589 | Mrsa Select - Skin and Soft Tissue Wound SpecimensJSO · Traditional | 10/29/2010SE |
| K081362 | Platelia Lyme IgmLSR · Traditional | 06/26/2008SE |
| K081212 | Mrsaselect - Extended IncubationJSO · Traditional | 06/13/2008SE |
| K080012 | Platelia Lyme Igg AssayLSR · Traditional | 05/08/2008SE |
| K070361 | MrsaselectJSO · Traditional | 09/13/2007SE |
| K060641 | Platelia Aspergillus Eia, Model 62793NOM · Traditional | 06/02/2006SE |
| K052838 | Liquichek Diabetes Control, Level 1,2,3,4GGM · Traditional | 11/09/2005SE |
| K052053 | Liquichek Qualitative Urine Toxicology Control, Negative, Positive, MinipakDIF · Traditional | 08/09/2005SE |
| K050537 | Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT…JJY · Traditional | 04/27/2005SE |
| K050536 | Quest Diagnostics Immunoassay/Tdm ControlJJY · Traditional | 03/24/2005SE |
| K043208 | Liquid Assayed Multiqual ControlJJY · Traditional | 01/07/2005SE |
| K042865 | Liquichek Urine Toxicology Control, (Levels S1S and S2S)DIF · Traditional | 11/24/2004SE |
| K042836 | Liquichek Reticulocyte Control (a)JPK · Traditional | 11/05/2004SE |
| K042815 | Quest Tumor Marker Control, Model 955JJY · Traditional | 11/05/2004SE |
| K042837 | Liquichek Elevated CRP ControlJJX · Traditional | 11/02/2004SE |
| K042324 | Lyphochek Elevated Immunosuppressant Control, Level 4, 5JJY · Traditional | 10/07/2004SE |
| K041561 | Liquichek Whole Blood Volatiles ControlDIF · Traditional | 07/06/2004SE |
| K041457 | Liquichek Hematology Control (a)JPK · Traditional | 06/28/2004SE |
| K040275 | Lyphochek Hemostasis ControlGGN · Traditional | 02/27/2004SE |
| K033404 | Liquichek Urine Toxicology Control (Confirmatory Series)DIF · Traditional | 12/12/2003SE |
| K033366 | Liquichek Qualitative Urine Toxicology Control, Negative, Model 454; Positive, Model 455DIF · Traditional | 12/12/2003SE |
| K033387 | Quest Diagnostics Serum Chemistry Control, Models 935 and 945JJY · Traditional | 12/02/2003SE |
| K032611 | Lyphochek Coagulation Control, Level 4, Model 743GGN · Special | 09/17/2003SE |
| K032017 | Liquichek D-Dimer Control Level 1, 2 and 3GGN · Traditional | 08/08/2003SE |
| K031231 | Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control Level 2…JJW · Traditional | 06/18/2003SE |
| K023857 | Platelia Aspergillus Eia, Models 62793 and 62794NOM · Traditional | 05/16/2003SE |
| K030182 | Liquichek D-Dimer Control, Model 356, 357GGN · Traditional | 02/24/2003SE |
| K024232 | Liquichek Anti-Ss-B Control, Positive, Catalog #113LKJ · Traditional | 01/17/2003SE |
| K024220 | Liquichek Autoimmune Negative Control, Catalog #130DHN · Traditional | 01/17/2003SE |
| K024218 | Liquichek Anti-Ss-A Control, Positive, Catalog #114LKJ · Traditional | 01/17/2003SE |
| K024230 | Liquichek Ana Control Set, Positive: Homogeneous, Speckled, Centromere and Nucleolar…DHN · Traditional | 01/15/2003SE |
| K024229 | Liquichek Ana Control, Nucleolar Pattern, Positive, Catalog #111DHN · Traditional | 01/15/2003SE |
| K024227 | Liquichek Anti-Mitochondrial Control, Positive, Catalog #127DHN · Traditional | 01/15/2003SE |
| K024225 | Liquichek Anti-Ndna Control, Positive, Catalog #119DHN · Traditional | 01/15/2003SE |
| K024224 | Liquichek Anti-Smooth Muscle Control, Positive, Catalog #129DHN · Traditional | 01/15/2003SE |
| K024222 | Liquichek Ana Control Centromere Pattern, Positive, Catalog #112DHN · Traditional | 01/15/2003SE |
| K024221 | Liquichek Ana Control Homogeneous Pattern Control, Posotive, Catalog #118DHN · Traditional | 01/15/2003SE |
| K024219 | Liquichek Anti-Sm Control, Positive, Catalog #115LKP · Traditional | 01/15/2003SE |
| K024217 | Liquichek Ana Control, Speckled Pattern, Positive, Catalog #108DHN · Traditional | 01/15/2003SE |
| K024231 | Liquichek Anti-Mitotic Spindle Pattern Control, Positive, Catalog #118DHN · Traditional | 01/13/2003SE |
| K024223 | Liquichek Anti-Rnp Control, Positive, Catalog #116LKJ · Traditional | 01/13/2003SE |
| K024226 | Liquichek ANTI-SCL-70 Control, Positive, Catalog #116LKJ · Traditional | 01/10/2003SE |
| K013839 | Bio-Rad Platelia Toxo Igg TMBLGD · Traditional | 09/30/2002SE |
| K013837 | Bio-Rad Platelia Toxo Igm TMBLGD · Traditional | 09/30/2002SE |
| K022991 | Liquichek Immunology Control Level 1, 2, and 3-1 ML, Model 591, 592, 593; Level 1, 2…JJY · Traditional | 09/17/2002SE |
| K022707 | Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439DIF · Traditional | 08/22/2002SE |
| K022529 | Liquichek Blood Gas Plus Co-Oximeter Control (Il Synthesis Series) Levels 1,2, and 3…JJS · Traditional | 08/15/2002SE |
| K022525 | Liquichek Blood Gas Plus Co-Oximeter Control (Radiometer 700 Series) Levels, 1,2 and 3…JJS · Traditional | 08/15/2002SE |
| K021415 | Liquichek Urine Toxicology Control Level C2 Low Opiate & C3 Low Opiate Models 468 & 469DIF · Traditional | 05/29/2002SE |
| K021414 | Liquichek Urine Toxicology Control Level S1 Low Opiate & S2 Low Opiate Models 466 & 467DIF · Traditional | 05/29/2002SE |
| K021411 | Liquichek Urine Toxicology Control Level S1, S2 & S3 Models 461, 462 & 463DIF · Traditional | 05/29/2002SE |
| K021384 | Liquichek Urine Toxicology Control Levels C1-C4, Models 441,442,443,444DIF · Traditional | 05/29/2002SE |
| K021498 | Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelJJT · Traditional | 05/24/2002SE |
| K020610 | Lyphochek Whole Blood Metals Control Model # 527, 528, 529DIE · Traditional | 04/22/2002SE |
| K020878 | Lyphochek Hemostasis, Models 798, 799GGC · Traditional | 04/15/2002SE |
| K012722 | Lyphochek Coagulation Control Level 1, Lyphochek Coagulation Level 2, Lyphochek…GGN · Traditional | 09/18/2001SE |
| K012741 | Liquichek TDM ControlDIF · Traditional | 09/12/2001SE |
| K012656 | Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648JJT · Traditional | 09/06/2001SE |
| K012513 | Liquichek Lipids Control Level 1, Liquichek Lipids Control Level 2, Models 641 and 642JJY · Traditional | 08/29/2001SE |
| K011853 | Abbott Tumormarker-Mcc (Lyophilized), Levels 1 and 2, 2ML No. 6E21-10JJY · Traditional | 07/17/2001SE |
| K011867 | Liquid Assayed Multiqual Control LEVEL1 #981600; Level 2 #981700; Level 3 #981800JJY · Traditional | 07/12/2001SE |
| K011579 | Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580JJY · Traditional | 06/26/2001SE |
| K011494 | Liquichek Immunology Control Level 1,2,3,1, ML, Liquichek Immunology Control Level 1, 3…JJY · Traditional | 06/08/2001SE |
| K003280 | Variant II Total GHBLCP · Traditional | 12/19/2000SE |
| K003242 | Liquichek Blood Gas Plus Co-Oximeter Control (Il), Model 621,622,623JJS · Traditional | 11/30/2000SE |
| K003239 | Liquichek Blood Gas Plus Co-Oximeter Control (800 Series), MODEL504,505,506JJS · Traditional | 11/30/2000SE |
| K003030 | Lyphochek Hemoglobin Alc Linearity SetGGM · Traditional | 11/29/2000SE |
| K002866 | Liquichek Blood Gas Plus E Control Level 4, Model 574JJS · Traditional | 09/25/2000SE |
| K002865 | Liquichek Blood Gas Plus E Control, Model 576, 577, 578JJS · Traditional | 09/25/2000SE |
| K002460 | Liquichek Lipids Control, Model 641, 642JJY · Traditional | 08/31/2000SE |
| K002536 | Liquichek Blood Gas Plus Co-Oximeter Control, Models 637, 638, 639 (Radiometer)JJS · Traditional | 08/30/2000SE |
| K002535 | Liquichec Blood Gas Pluse Control with Glucose, Model 511, 512, 513JJS · Traditional | 08/30/2000SE |
| K002120 | Liquichek Blood Gas Control, Model 571, 572, 573JJS · Traditional | 08/21/2000SE |
| K002196 | Lyphochek Fertility Control, Models 480, 481, 482, 483JJY · Traditional | 08/07/2000SE |
| K001373 | Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363JJY · Traditional | 05/25/2000SE |
| K000875 | Assayed QCS 1,2, Cat. Nos. 970200, 970500JJY · Traditional | 04/20/2000SE |
| K000874 | Urine Control 1, Cat. No. 903600, Urine Control 2, Cat. No. 904100JJW · Traditional | 04/18/2000SE |
| K992781 | Architech Afp Mastercheck, Model 6C01-05JJX · Traditional | 04/05/2000SE |
| K993107 | Bio-Rad Homocysteine by HPLCLPS · Traditional | 12/21/1999SE |
| K992741 | Lyphochek Anemia Control, Model 500JJY · Traditional | 11/09/1999SE |
| K993536 | Bio-Rad Coda Neonatal Galt AssayKQP · Special | 11/04/1999SE |
| K992172 | Lyphochek Tumor Marker Control, Model 580JJY · Traditional | 09/02/1999SE |
| K992550 | Liquichek Immunology Control Level 1, 2, 3JJY · Traditional | 08/11/1999SE |
| K991127 | Variant II B-ThalassemiaJPD · Special | 06/10/1999SE |
| K990610 | Abbott Tumor Marker-Mcc (Lyophilized), Model 6E21-10JJY · Traditional | 04/27/1999SE |
| K990858 | Lypochek Coagulation Control, Model Nos. 787, 788, 789GGN · Traditional | 04/21/1999SE |
| K990928 | Lyphocheck Urine Metals Control, Item NO.400, 405DIE · Traditional | 04/16/1999SE |
| K990827 | Microplate Neonatal Galt AssayKQP · Special | 04/09/1999SE |
| K990888 | Modification to Liquichek Spinal Fluid Control, Item Nos. 751, 752JJY · Traditional | 04/07/1999SE |
| K990587 | Abbott Liquid RF Control, Models 2E04-01, 2E05-01, 2E06-01DHR · Traditional | 04/07/1999SE |
| K990424 | Abbott Liquid Immunology Control Models 2E01-01/2E02-01/2E03-01JJY · Traditional | 03/31/1999SE |
| K990608 | Architect Cea Mastercheck, Model 6CO2-05JJX · Traditional | 03/30/1999SE |
| K990393 | Architect Progesterone Mastercheck Model #6C26-05JJX · Traditional | 03/22/1999SE |
| K990394 | Abbott Lyophilized Assayed Chemistry Control Models #1E86-02/#1E87-02JJY · Traditional | 03/18/1999SE |
| K990317 | Abbot Liquid Urine Chemistry Control, Model 1E96-01/1E97-01JJY · Traditional | 03/18/1999SE |
| K990391 | Abbott Lyophilized Assayed Chemistry Control 3 Model #4E39-01JJY · Traditional | 03/15/1999SE |
| K990282 | Abbott Liquid Assayed Chemistry Control, Model 1E81-01/1E82-01JJY · Traditional | 03/09/1999SE |
| K984625 | Architect Folate Masterchek, Model # 6C12-05JJX · Traditional | 02/02/1999SE |
| K984604 | Architect Estradiol Masterchek, Model # 6C22-05JJX · Traditional | 02/02/1999SE |
| K984594 | Lyphochek Maternal Serum Control, Model 220JJY · Traditional | 02/02/1999SE |
| K984626 | Architect B12 Masterchek, Model # 6C09-O5JJX · Traditional | 01/29/1999SE |
| K984477 | Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528, 529JJY · Traditional | 01/29/1999SE |
| K990162 | Abbott Liquid Ammonia Control, Model #'S 1E93-01,1E94-01,1E95-01JJX · Traditional | 01/28/1999SE |
| K990161 | Abbott Liquid CSF Control, Model #'S 1E98-01, 1E99-01JJY · Traditional | 01/28/1999SE |
| K990150 | Abbott Liquid Lipids Chemistry, Model #'S 3E18-01, 3E19-01JJY · Traditional | 01/26/1999SE |
| K990149 | Abbott Liquid Pediatric Chemistry Control, Model # 4E37-01, 4E38-01JJY · Traditional | 01/26/1999SE |
| K990017 | Abbott Immunoassay-Mcc (Liquid) Control, Model Number 6E20-10JJY · Traditional | 01/25/1999SE |
| K984479 | Liquichek Anti-Sm Control, Eia, Model 208LKP · Traditional | 12/22/1998SE |
| K984478 | Liquichek Anti-Ss-B Control, Eia, Model 210LKJ · Traditional | 12/22/1998SE |
| K984476 | Liquichek Anti-Rnp Control, Eia, Model 207LKO · Traditional | 12/22/1998SE |
| K984475 | Liquichek ANTI-SCL-70 Control, Eia, Model 212LKJ · Traditional | 12/22/1998SE |
| K984473 | Liquichek Ana Control, Eia Screen, Model 205LKJ · Traditional | 12/22/1998SE |
| K984470 | Liquichek Anti-Ss-A Control, Eia, Model 209LKJ · Traditional | 12/22/1998SE |
| K984464 | Liquichek Anti-Jo 1 Control, Eia, Model No. 211LKJ · Traditional | 12/22/1998SE |
| K984462 | Liquichek Ena Control, Eia Screen, Model No. 206LLL · Traditional | 12/22/1998SE |
| K984327 | Architect Total T3 Mastercheck, Model Number 6C51-05JJX · Traditional | 12/22/1998SE |
| K984319 | Architect Free T3 Mastercheck, Model Number 6C48-05JJX · Traditional | 12/22/1998SE |
| K984400 | Liquichek Ana Control, Speckled Pattern, Model 202DHN · Traditional | 12/18/1998SE |
| K984399 | Liquichek Ana Control, Nucleolar Pattern, Model 204DHN · Traditional | 12/18/1998SE |
| K984398 | Liquichek Ana Control, Homogeneous Pattern, Model 201DHN · Traditional | 12/18/1998SE |
| K984397 | Liquichek Ana Control, Centromere Pattern, Model 203DHN · Traditional | 12/18/1998SE |
| K984396 | Liquichek Anti-Dsdna Control, Model 213LRM · Traditional | 12/18/1998SE |
| K984325 | Architect Ferritin Mastercheck, Model Number 6C11-05JJY · Traditional | 12/17/1998SE |
| K984268 | Variant II Hemoglobin A1C ProgramLCP · Traditional | 12/17/1998SE |
| K983807 | Lyphochek Tumor Marker Control, Model #580JJY · Traditional | 12/16/1998SE |
| K984324 | Architect Prolactin Mastercheck, Model Number 6C27-05JJX · Traditional | 12/15/1998SE |
| K984323 | Architect LH Mastercheck, Model Number 6C25-05JJX · Traditional | 12/15/1998SE |
| K984318 | Architect FSH Mastercheck, Model Number 6C24-05JJX · Traditional | 12/15/1998SE |
| K984225 | Liquichek Serum Volatiles Control, Models 383 and 384JJY · Traditional | 12/14/1998SE |
| K984071 | Liquichek Homocysteine Control, Cat #644JJX · Traditional | 12/03/1998SE |
| K984073 | Architect Total P-Hcg Mastercheck, List No. 6C21-05JJX · Traditional | 11/25/1998SE |
| K984070 | Architect Free T4 Mastercheck, List No. 6C50-05JJX · Traditional | 11/25/1998SE |
| K984072 | Architect TSH Mastercheck, List No, 6C52-05JJX · Traditional | 11/24/1998SE |
| K984074 | Architect Total T4 Mastercheck, List No. 6C49-05JJY · Traditional | 11/20/1998SE |
| K983578 | Architect Testosterone Mastercheck, Model 6C28-05JJX · Traditional | 11/12/1998SE |
| K981590 | Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level…DIF · Traditional | 06/10/1998SE |
| K981532 | Lyphochek Immunoassay Plus ControlJJY · Traditional | 05/12/1998SE |
| K980871 | Lyphochek Whole Blood ControlDIF · Traditional | 04/06/1998SE |
| K980556 | Liquichek Cardiac Markers Control LTJJT · Traditional | 02/25/1998SE |
| K973350 | Bio-Rad Microplate 17-HYDROXYPROGESTERONE TestJLX · Traditional | 02/09/1998SE |
| K972609 | Variant Express Glycohemoglobin ProgramLCQ · Traditional | 08/06/1997SE |
| K972024 | Coda Automated Eia AnalyzerJJI · Traditional | 07/30/1997SE |
| K972174 | Lyphochek Remedi ControlDIF · Traditional | 06/24/1997SE |
| K971952 | Lyphochek Hypertension Markers Control (Cat. No. 600)JJY · Traditional | 06/16/1997SE |
| K971954 | Liquichek Urine Chemistry Control (Cat.No. 397,398)JJY · Traditional | 06/11/1997SE |
| K963018 | Bio-Rad Serum Proteins by Capillary ElectrophoresisCEF · Traditional | 06/04/1997SE |
| K971691 | Liquichek Urine Toxicology Control - Level S1, S2, S3DIF · Traditional | 05/30/1997SE |
| K970666 | Liquicheck Urine Toxicology Negative ControlDIF · Traditional | 03/10/1997SE |
| K964963 | Lyphochek Coagulation ControlGGN · Traditional | 02/20/1997SE |
| K965171 | Liquichek Urianlysis Control (Cat. No. 420,421,422,425,426)JJY · Traditional | 01/13/1997SE |
| K961432 | Radias Galt TestJJX · Traditional | 10/28/1996SE |
| K963040 | Manual Phenylalanine TestJNB · Traditional | 10/01/1996SE |
| K961941 | Liquichek Immunoassay Plus Control Catalog No. 360,361,362,363JJY · Traditional | 09/16/1996SE |
| K960437 | Radias Phenylalanine TestJNB · Traditional | 08/16/1996SE |
| K960392 | CDMLDM · Traditional | 07/08/1996SE |
| K961828 | Liquichek Cardiac Markers Control (Cat. No. 685,686,687,688)JJT · Traditional | 06/11/1996SE |
| K960987 | Liquichek Rheumatoid Factor ControlDHR · Traditional | 06/04/1996SE |
| K955355 | Variant Alpha-Thalassemia Short ProgramGKA · Traditional | 04/26/1996SE |
| K955153 | Lyphochek Benzo/Tca Control-Set BDIF · Traditional | 02/05/1996SE |
| K955116 | Benzodiazepines by Remedi HSLAA · Traditional | 01/30/1996SE |
| K955024 | Liquichek Ethanol/Ammonia ControlJJY · Traditional | 11/28/1995SE |
| K954048 | Variant Hemoglobinopathy ProgramGKA · Traditional | 11/20/1995SE |
| K951321 | Radias Neonatal T4 Enzyme ImmunoassayKLI · Traditional | 08/24/1995SE |
| K952817 | Bio-Rad Urinary 5-HIAA by HPLCCDA · Traditional | 08/01/1995SE |
| K945651 | Liquichek(Tm Immunology Control, Levels 1.2. and 3JJY · Traditional | 05/16/1995SE |
| K941616 | Variant Total GHB ProgramLCP · Traditional | 04/14/1995SE |
| K941596 | Remedi HS Drug Profiling SystemDNI · Traditional | 03/27/1995SE |
| K941994 | Benzodiazepines and Tricyclic Antidepressants by HPLCLFI · Traditional | 03/20/1995SE |
| K941990 | Benozodiazepines and Tricylic Antidepressants by HPLCLFI · Traditional | 03/20/1995SE |
| K946163 | Radias Total T4 Enzyme ImmunoassayKLI · Traditional | 02/22/1995SE |
| K944212 | Radias Red Cell Folate ImmunoasayCGN · Traditional | 02/03/1995SE |
| K935399 | Radias Neonatal TSH Enzyme ImmunoassayJLW · Traditional | 12/19/1994SE |
| K942451 | Bio-Rad Clinical Data Management SystemLDM · Traditional | 11/10/1994SE |
| K941509 | Radias Ana Screen Enzyme ImmunoassayLJM · Traditional | 06/30/1994SE |
| K942209 | Liquichek HEMATOLOGY-16 Control, Low, Normal and HighJCN · Traditional | 06/16/1994SE |
| K935119 | Radias 3RD Generation TSH ImmunoassayJLW · Traditional | 04/06/1994SE |
| K935613 | Radias Monoclonal Hba 1C AssayLCP · Traditional | 04/05/1994SE |
| K935286 | Quantaphase II B12/FOLATECGN · Traditional | 02/18/1994SE |
| K934357 | Liquichek Routine Urime Chemistry Control, Levels 1 & 2JJY · Traditional | 10/21/1993SE |
| K933571 | Radias Folate Enzyme ImmunoassayCGN · Traditional | 10/01/1993SE |
| K933314 | Radias Ferritin Enzyme ImmunoassayDEW · Traditional | 09/08/1993SE |
| K933315 | Radias B12 Enzyme ImmunoassayCDD · Traditional | 08/25/1993SE |
| K931740 | Cotube Estradiol RadioimmunoassayCHP · Traditional | 08/16/1993SE |
| K933317 | Lyphochek Endocrine Control, Levels 1 and 2JJY · Traditional | 08/11/1993SE |
| K922590 | Bio-Pen SRK II CalculatorLQB · Traditional | 08/03/1993SE |
| K932643 | Lyphochek(R) Urine Toxicology Screen-Low ControlDIF · Traditional | 07/08/1993SE |
| K932076 | Liquichek Spinal Fluid Control Levels I and IIJJY · Traditional | 06/29/1993SE |
| K921443 | Tip & Membrane AssemblyHKX · Traditional | 06/22/1993SE |
| K931061 | Radias TSH Enzyme ImmunoassayJLW · Traditional | 06/16/1993SE |
| K931110 | Radias Free T4 Enzyme ImmunoassayCEC · Traditional | 05/20/1993SE |
| K930898 | Radias Automated Immunoassay SystemJJI · Traditional | 04/21/1993SE |
| K926469 | Variant(Tm) Hemoglobin a 1C ProgramLCP · Traditional | 03/29/1993SE |
| K924122 | Variant Beta-Thalassemia Short ProgramJPD · Traditional | 03/11/1993SE |
| K924813 | Variant Sickle Cell Short ProgramGKA · Traditional | 01/14/1993SE |
| K925151 | Liquichek Ck-Mb Control Levels 1,2, AND3JJT · Traditional | 12/17/1992SE |
| K923578 | Liquichek Rheumatoid Factor ControlDHR · Traditional | 10/06/1992SE |
| K921949 | Cotube PTH IrmaCEW · Traditional | 09/02/1992SE |
| K921617 | Cylinder of Gas, Can of Gas (CC12F2)HKX · Traditional | 08/05/1992SE |
| K922046 | Lyphochek Unassayed Chemistry Control Level 3JJY · Traditional | 07/10/1992SE |
| K921286 | Liquichek Lipids Control Levels 1 and 2JJY · Traditional | 06/09/1992SE |
| K921089 | Lyphochek(R) Fructosamine ControlJJX · Traditional | 04/29/1992SE |
| K914255 | Liquichek(R) Unassayed Chemistry Contr(Human) 1&2JJY · Traditional | 01/09/1992SE |
| K913315 | Bio-Rad Total Protein Test KitCEF · Traditional | 01/02/1992SE |
| K914170 | Liquichek Therapeutic Drug Monitoring Control(Tdm)DIF · Traditional | 11/22/1991SE |
| K911347 | Lyphochek(R) Hemoglobin A2 ControlJCM · Traditional | 06/10/1991SE |
| K911954 | Remedi(Tm) Drug Profiling System, ModificationDJR · Traditional | 05/23/1991SE |
| K910829 | Lyphochek Benzo/Tca Control Serum, Levels 1 and 2LAS · Traditional | 04/03/1991SE |
| K903311 | Novapath TSH Enzyme ImmunoassayJLW · Traditional | 09/07/1990SE |
| K903430 | Liquichek Ck/Ld Isoenzyme Control; Levels 1 and 2JJT · Traditional | 08/23/1990SE |
| K901270 | Lyphochek Urine Toxicology Control - ScreenDIF · Traditional | 05/02/1990SE |
| K901271 | Lyphochek Urine Toxicology Control - ConfirmDIF · Traditional | 04/11/1990SE |
| K900776 | Novapath Microplate ReaderJJQ · Traditional | 04/03/1990SE |
| K900775 | Novapath SP Advanced Liquid Handling SystemJQW · Traditional | 03/09/1990SE |
| K896744 | Benzodiazepines/Tricyclic Antidepressants by HPLCJXM · Traditional | 02/23/1990SE |
| K896168 | Hemoglobin A2 Micro Column TestJPD · Traditional | 01/18/1990SE |
| K895905 | Lyphochek Whole Blood Control (Human) Levels 1,2,3JJY · Traditional | 01/18/1990SE |
| K891691 | Lyphochek Urine Metals Control, Levels I and IIDIE · Traditional | 12/19/1989SE |
| K895816 | Bio-Rad Blind Perfor. Specimen Set for Nida Reg.DIF · Traditional | 12/07/1989SE |
| K895575 | Bio-Rad Modular Air CompressorHKX · Traditional | 10/31/1989SE |
| K894966 | Plasma Catecholamines by HPLCCHQ · Traditional | 10/25/1989SE |
| K894078 | Lyphochek(R) Tumor Marker Controls, Levels I & IIJJY · Traditional | 08/11/1989SE |
| K894252 | Lyphochek Immunoassay Plus Control SerumJJY · Traditional | 08/01/1989SE |
| K891475 | Lyphochek(R) Immunoassay Contr Serum (Human) 1,2,3JJX · Traditional | 08/01/1989SE |
| K891680 | Lyphochek Tumor Marker Controls, Levels I and IIJJY · Traditional | 06/13/1989SE |
| K892004 | Liquichek(R) Serum Alcohol Control; Levels 1,2 & 3LAS · Traditional | 04/21/1989SE |
| K890802 | Cotube(Tm) TSH IrmaJLW · Traditional | 03/28/1989SE |
| K884498 | Cotube LH Irma AssayCEP · Traditional | 12/22/1988SE |
| K884424 | Lyphochek Routine Urine Controls 1 & 2 (Human)JJW · Traditional | 12/15/1988SE |
| K884342 | Novapath Specimen Collection KitLIO · Traditional | 11/03/1988SE |
| K882486 | Lyphochek Unassayed Chem. Control (Human) I and IIJJY · Traditional | 10/25/1988SE |
| K882155 | Cotube HCG Irma TestJHI · Traditional | 08/08/1988SE |
| K882222 | Determin Hemoglobin Alc/Hi Perf Liq ChromatographyLCP · Traditional | 08/01/1988SE |
| K882051 | Bio-Rad Hemoglobin DetectorLCP · Traditional | 08/01/1988SE |
| K882542 | Lyphochek Unassayed Chemistry Control (Bovine)I/IiJJY · Traditional | 07/21/1988SE |
| K881991 | Lyphochek Urine Toxicology Control - NegativeDIF · Traditional | 06/20/1988SE |
| K881990 | Lyphochek Urine Toxicology Control - LowDIF · Traditional | 06/20/1988SE |
| K881989 | Lyphochek Urine Toxicology ControlDIF · Traditional | 06/20/1988SE |
| K880145 | Lyphochek Therapeutic Drug Monitoring ControlDIF · Traditional | 06/20/1988SE |
| K880445 | Lyphochek Urine Toxicology Control - LowDIF · Traditional | 04/05/1988SE |
| K880496 | Lyphochek Quantitative Urine Control Normal (1)JJW · Traditional | 03/16/1988SE |
| K880495 | Lyphochek Quantitative Urine Control Abnormal (2)JJW · Traditional | 03/15/1988SE |
| K880494 | Lyphochek Spinal Fluid Control (Human)JJY · Traditional | 03/03/1988SE |
| K880444 | Lyphochek Urine Toxicology Control - NegativeDIF · Traditional | 02/25/1988SE |
| K875102 | Deter. of Hemoglobin A2 Using the DiamatJPD · Traditional | 02/24/1988SE |
| K874731 | Lyphochek Whole Blood ControlJJY · Traditional | 02/18/1988SE |
| K874280 | Lyphochek Assayed Chemistry Control (Human), I/IiJJY · Traditional | 01/21/1988SE |
| K873371 | Urinary Free Catecholamines & Metanephrines (HPLC)CHQ · Traditional | 01/05/1988SE |
| K873372 | Hva & Homovanillic Acid by HPLC MethodCDF · Traditional | 12/22/1987SE |
| K872227 | Liquichek Pediatric Control Levels I and IIJJY · Traditional | 07/06/1987SE |
| K871388 | Micromat Model 415 - Bichromatic Filter PhotometerLCP · Traditional | 07/06/1987SE |
| K871860 | Novapath C. Trachomatis Direct Spec Collection KitLIO · Traditional | 05/29/1987SE |
| K870121 | Digilab Micro One Applanation TonometerHKX · Traditional | 02/20/1987SE |
| K870120 | Digilab Model 1500 PerimeterHPT · Traditional | 02/20/1987SE |
| K865014 | Liquichek Immunology Control (Human) Levels I & IIDGR · Traditional | 01/09/1987SE |
| K864137 | Lyphochek Immunoassay Serum Control Level I,Ii,IiiKIJ · Traditional | 11/07/1986SE |
| K863487 | Quantimune(R) Ferritin IrmaDBF · Traditional | 10/01/1986SE |
| K863217 | Digilab Modular One-Applanation TonometerHKX · Traditional | 09/24/1986SE |
| K862371 | Hemoglobin A1C by Column Test (Micro A1C)LCP · Traditional | 09/16/1986SE |
| K861970 | Lyphochek Urine Toxicology ControlDIF · Traditional | 08/19/1986SE |
| K862185 | Lyphochek Pediatric and Bilirubin ControlJJY · Traditional | 08/04/1986SE |
| K862186 | Lyphochek Glycated Hemoglobin/Whole Blood/Lev.I&IiJPK · Traditional | 07/01/1986SE |
| K861010 | Vma by HPLC Test (Vanilmandelic Acid)CDF · Traditional | 05/01/1986SE |
| K860288 | Echoclonal HTSH IrmaJLW · Traditional | 04/11/1986SE |
| K860629 | Biogram Apo A1/BMSJ · Traditional | 03/28/1986SE |
| K860115 | Digilab Cambridge PerimeterHOO · Traditional | 02/27/1986SE |
| K851636 | Diamat Glycoslated Hemoglobin Analyzer SystemLCP · Traditional | 07/30/1985SE |
| K852414 | Lyphochek Drug Free Serum(Human)DIF · Traditional | 07/24/1985SE |
| K852201 | Echoclonal HCG IrmaJHI · Traditional | 06/28/1985SE |
| K850191 | Digilab 750 Automated Perimeter W/Ibm Person/CompuHPT · Traditional | 03/04/1985SE |
| K844125 | Lyphochek Pregnancy Control Serum HumanJJY · Traditional | 01/08/1985SE |
| K843552 | Triglycerides Gpo ReagentCDT · Traditional | 09/26/1984SE |
| K833794 | Lyphochek Therapeutic Drug ControlDIF · Traditional | 01/24/1984SE |
| K833247 | Quantaphase B-12-COBALMIN-FOLATE-CDD · Traditional | 10/19/1983SE |
| K832695 | Lyphochek Serum Ref. Standard-BovineJIX · Traditional | 10/04/1983SE |
| K832175 | Digilab 350 the Krakau PerimeterHPT · Traditional | 08/16/1983SE |
| K831053 | Quantigen T & B Cell AssayLIZ · Traditional | 08/08/1983SE |
| K831742 | Quantimune HFSH Ria Human Follicle-CGJ · Traditional | 07/18/1983SE |
| K831478 | Lyphochek Hemoglobin Aic Control HumanLCP · Traditional | 06/22/1983SE |
| K830935 | Hemoglobin Alc by Column TestLCP · Traditional | 06/16/1983SE |
| K822977 | Hemoglobin Alc by Column TestLCP · Traditional | 11/16/1982SE |
| K822291 | Quantimune HTSH IrmaJLW · Traditional | 08/27/1982SE |
| K821346 | Quantimune HLH RiaCEP · Traditional | 05/28/1982SE |
| K820728 | Quantimune Estriol RiaCGI · Traditional | 04/06/1982SE |
| K811710 | Bio.Rad Hemoglobin A1 by Column TestLCP · Traditional | 07/15/1981SE |
| K811856 | Fluoromatic Theophylline FiaLER · Traditional | 07/10/1981SE |
| K811787 | Quantaphase T-4 RiaCDX · Traditional | 07/10/1981SE |
| K811709 | Quantimune Estriol RiaCGI · Traditional | 07/10/1981SE |
| K811177 | Quanta Phase Vitamin B-12/FOLATE RadCGN · Traditional | 05/15/1981SE |
| K810799 | Quantimune Ferritin IrmaJMG · Traditional | 04/03/1981SE |
| K810302 | Quantimune HLH Ria Human Lutenizing HormCEP · Traditional | 02/25/1981SE |
| K802944 | Quantimune E3 RiaCGI · Traditional | 12/22/1980SE |
| K800090 | Fluoromatic Phenolbarbital FiaDKP · Traditional | 01/23/1980SE |
| K800045 | Quantimune Cortisol Ria Cortisol Radio-CGR · Traditional | 01/23/1980SE |
| K792640 | Fluoromatic Phenytoin FiaDLP · Traditional | 01/11/1980SE |
| K791837 | Vma by Column TestCDF · Traditional | 10/30/1979SE |
| K791770 | Quantimune Gentamicin Ria GentamicinDJB · Traditional | 10/17/1979SE |
PMA approvals
- P880032 Bio-Rad Cyclosporine by HPLC Test · 07/24/1989 · 2 supplements