Boehringer Mannheim Corp.
Medical device manufacturer in Indianapolis, IN.
340510(k) clearances
1PMA approvals
0recalls
Device types
- JJX Single (Specified) Analyte Controls… 24
- CGA Glucose Oxidase, Glucose 17
- JJY Multi-Analyte Controls, All Kinds (Assayed) 17
- JJE Analyzer, Chemistry (Photometric… 16
- LFR Glucose Dehydrogenase, Glucose 9
- JIX Calibrator, Multi-Analyte Mixture 8
- CHH Enzymatic Esterase--Oxidase, Cholesterol 7
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 6
- MMI Immunoassay Method, Troponin Subunit 6
- KQO Automated Urinalysis System 6
- LTJ Prostate-Specific Antigen (Psa) For… 5
- JIS Calibrator, Primary 5
- KNK Acid, Uric, Uricase (Colorimetric) 5
- CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 5
- JJQ Colorimeter, Photometer, Spectrophotometer… 4
- KXT Enzyme Immunoassay, Digoxin 4
- CDQ Urease And Glutamic Dehydrogenase, Urea… 4
- KHS Enzymatic, Carbon-Dioxide 4
- CDP Radioimmunoassay, Total Triiodothyronine 4
- JFY Enzymatic Method, Creatinine 4
510(k) clearances (latest 300)
| 510(k) | Device | Decision |
|---|---|---|
| K984326 | Elecys Ige AssayJHR · Traditional | 02/08/1999SE |
| K983047 | Accu-Chek HQ SystemLFR · Traditional | 02/05/1999SE |
| K984419 | Elecsys Ige CalcheckJJY · Traditional | 02/02/1999SE |
| K984425 | Modification of Preciset Serum Proteins CalibratorJIX · Traditional | 01/20/1999SE |
| K984372 | Elecsys Calcheck Troponin TJJY · Traditional | 12/14/1998SE |
| K984105 | Elecsys Troponin T Stat TestMMI · Traditional | 12/08/1998SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | 12/01/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | 11/25/1998SE |
| K983185 | Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional | 11/12/1998SE |
| K983510 | Chemstrip 101 Urine AnalyzerKQO · Special | 10/27/1998SE |
| K982949 | Elecsys Psa, Model 2010LTJ · Traditional | 10/27/1998SE |
| K982948 | Elecsys Psa, Model # Elecsys 1010LTJ · Traditional | 10/27/1998SE |
| K983416 | Roche Diagnostics Magnesium Reagent, Cat# 1551353JGJ · Traditional | 10/21/1998SE |
| K980724 | Tinaquant B 2-MICROGLOBULIN AssayJZG · Traditional | 10/16/1998SE |
| K983492 | Boehringer Mannheim Elecsys Presicontrol CardiacJJY · Traditional | 10/09/1998SE |
| K983176 | Elecsys Myoglobin Stat AssayDDR · Traditional | 09/24/1998SE |
| K983166 | Elecsys Calcheck MyoglobinJJY · Traditional | 09/22/1998SE |
| K982089 | Accu-Chek Advantage Test Strips and Accu-Chek Advantage H Test StripsLFR · Traditional | 09/03/1998SE |
| K982002 | Accu-Chek Comfort Curve Test StripLFR · Traditional | 09/02/1998SE |
| K982079 | Accu-Check VoicemateLFR · Traditional | 08/28/1998SE |
| K982471 | B2-MICROGLOBULIN Control Set SerumJJX · Traditional | 08/06/1998SE |
| K981883 | Roche Diagnostics, Boehringer Mannheim Corporation Liquid Direct Bilirubin Reagent…CIG · Traditional | 07/07/1998SE |
| K980887 | Elecsys Cea on the Elecsys 1010DHX · Traditional | 06/29/1998SE |
| K980746 | Cedia Dau Eddp AssayDJR · Traditional | 05/26/1998SE |
| K980731 | Accu-Chek Comfort Curve Test StripsLFR · Traditional | 05/22/1998SE |
| K981401 | Boehringer Mannheim Precinorm Precipath Protein ControlsJJY · Traditional | 05/18/1998SE |
| K974491 | Accu-Chek A1C Hemoglobin TestLCP · Traditional | 05/13/1998SE |
| K980853 | Cedia Dau Multi-Drug CalibratorsDKB · Traditional | 04/21/1998SE |
| K980240 | Elecsys Ca 125II on the Elecsys 1010LTK · Traditional | 03/25/1998SE |
| K972162 | Elecsys Ca 125 IILTK · Traditional | 03/18/1998SE |
| K973523 | Accustat H. Pylori One Step TestLYR · Traditional | 03/03/1998SE |
| K974825 | Boehringer Mannheim C.F.A.S. - Hdl/Ldl-C-PlusJIX · Traditional | 01/30/1998SE |
| K974733 | Boehringer Mannheim Direct LDL - CholesterolLBR · Traditional | 01/26/1998SE |
| K974826 | BM Precipath(R) Hdl/Ldl-C ControlJJY · Traditional | 01/22/1998SE |
| K974569 | Coaguchek System, Coaguchek System for Prothrombin Time Self TestingJPA · Traditional | 01/09/1998SE |
| K972640 | Tina-Quant Alpha PARTICLE-1-ANTITRYPSIN AssayDEM · Traditional | 01/09/1998SE |
| K972639 | Tina-Quant HaptoglobinDAD · Traditional | 01/09/1998SE |
| K972638 | Tina-Quant PrealbuminJZJ · Traditional | 01/09/1998SE |
| K974189 | Elecsys Psa (on Elecsys 1010)LTJ · Traditional | 01/06/1998SE |
| K974421 | Elecsys Ck-Mb StatJHY · Traditional | 12/17/1997SE |
| K973662 | Accu-Chek(R)Complete System/Meter & Accu-Chek Advantage Test Strips/Accu-Chek Advantage…LFR · Traditional | 12/15/1997SE |
| K974384 | Elecsys Calcheck FolateJJY · Traditional | 12/08/1997SE |
| K974383 | Elecsys Calcheck Vitamin B12JJX · Traditional | 12/08/1997SE |
| K973351 | Elecsys AfpLOJ · Traditional | 11/21/1997SE |
| K973702 | Elecsys Vitamin B12 AssayCDD · Traditional | 11/13/1997SE |
| K973674 | Elecsys FolateCDD · Traditional | 11/12/1997SE |
| K973973 | Elecsys Callcheck DigoxinDMP · Traditional | 11/04/1997SE |
| K973112 | Elecsys DigoxinKXT · Traditional | 10/10/1997SE |
| K972876 | Glucotrend Basic SystemLFR · Traditional | 10/09/1997SE |
| K973629 | Precinorm RF, Precipath RFJJY · Traditional | 10/07/1997SE |
| K973358 | Myoglobin Control SetJJX · Traditional | 10/06/1997SE |
| K972963 | Modified Cedia Dau PCP AssayLCM · Traditional | 09/22/1997SE |
| K972235 | Precicontrol Tumor Marker 1 and 2JJY · Traditional | 08/12/1997SE |
| K964282 | Tina-Quant Ferritin AssayJMG · Traditional | 07/30/1997SE |
| K972513 | Tinaquant Myoglobin AssayDDR · Traditional | 07/28/1997SE |
| K964351 | Elecsys Psa AssayLTJ · Traditional | 07/25/1997SE |
| K972433 | Cedia Digoxin CalibratorsDLJ · Traditional | 07/24/1997SE |
| K971060 | Precinorm TDM ControlsDIF · Traditional | 07/07/1997SE |
| K971379 | Tinaquant Rheumatoid Factor AssayDHR · Traditional | 06/17/1997SE |
| K964368 | Elecsys Cea AssayJIT · Traditional | 06/16/1997SE |
| K971833 | Elecsys FerritinJMG · Traditional | 06/02/1997SE |
| K970883 | Cedia Digoxin IIKXT · Traditional | 05/21/1997SE |
| K970881 | Cedia DigoxinKXT · Traditional | 05/14/1997SE |
| K962571 | Coaguchek PST SystemGJS · Traditional | 04/22/1997SE |
| K970984 | The Elecsys Calcheck ProgesteroneJJX · Traditional | 04/02/1997SE |
| K964841 | Elecsys Progesterone AssayJLS · Traditional | 03/24/1997SE |
| K965085 | Enzymun-Test PsaLTJ · Traditional | 03/19/1997SE |
| K964889 | Elecsys Testosterone AssayCDZ · Traditional | 03/18/1997SE |
| K970459 | Elecsys Calcheck CeaJJX · Traditional | 03/06/1997SE |
| K970458 | Elecsys Calcheck PsaJJX · Traditional | 03/06/1997SE |
| K970452 | Elecsys Calcheck CeaJJX · Traditional | 03/06/1997SE |
| K965109 | Elecsys Estradiol AssayCHP · Traditional | 02/18/1997SE |
| K970148 | Elecsys Calcheck EstradiolJJX · Traditional | 02/10/1997SE |
| K970147 | Elecsys Calcheck ProlactinJJY · Traditional | 02/10/1997SE |
| K964372 | Cardiac T Troponin T Rapid AssayMMI · Traditional | 02/10/1997SE |
| K970146 | Elecsys Calcheck TestosteroneJJX · Traditional | 01/30/1997SE |
| K964694 | Elecsys LH AssayCEP · Traditional | 01/24/1997SE |
| K964748 | Elecsys Prolactin AssayCFT · Traditional | 01/21/1997SE |
| K965157 | Cedia Dau Multi-Drug Control Cedia Dau Specialty Control Set 1DIF · Traditional | 01/17/1997SE |
| K964830 | Elecsys Calcheck LHJJX · Traditional | 12/16/1996SE |
| K964829 | Elecsys Calcheck FSHJIX · Traditional | 12/16/1996SE |
| K964693 | Elecsys FSH AssayCGJ · Traditional | 12/16/1996SE |
| K963127 | Elecsys FT3CDP · Traditional | 12/16/1996SE |
| K962734 | Cedia Dau Benzodiazepine AssayJXM · Traditional | 12/10/1996SE |
| K962760 | Enzymun-Test FT3CDP · Traditional | 11/29/1996SE |
| K963840 | Cedia Phenytoin II AssayDIP · Traditional | 11/20/1996SE |
| K962795 | Cedia Dau Opiate 2K AssayDJG · Traditional | 10/30/1996SE |
| K963306 | Cedia N-Acetylprocainamide AssayLAR · Traditional | 10/29/1996SE |
| K962269 | Cedia Cardiac TDM Multi-CalsJIX · Traditional | 10/29/1996SE |
| K963213 | Boehringer Mannheim Direct Hdl-CholesterolLBS · Traditional | 10/23/1996SE |
| K963191 | Cedia Antibiotic TDM Multi-CalsDKB · Traditional | 09/10/1996SE |
| K963181 | Elecsys Calcheck T UpdateJJX · Traditional | 09/10/1996SE |
| K963165 | Elecsys Calcheck HCGJJX · Traditional | 08/30/1996SE |
| K963178 | Elecsys Calcheck T4JJX · Traditional | 08/27/1996SE |
| K963167 | Elecys Calcheck T 3JJX · Traditional | 08/27/1996SE |
| K963164 | Elecsys Calcheck FT4JJX · Traditional | 08/27/1996SE |
| K963163 | Elecsys Calcheck FT3JJX · Traditional | 08/27/1996SE |
| K962099 | Cedia Procainamide AssayLAR · Traditional | 08/27/1996SE |
| K963182 | Elecsys Calcheck Ck-MbJJX · Traditional | 08/23/1996SE |
| K963147 | Elecsys Calcheck TSHJJX · Traditional | 08/23/1996SE |
| K963143 | Elecsys Calcheck Troponin TJJX · Traditional | 08/23/1996SE |
| K962508 | Elecsys T3CDP · Traditional | 08/15/1996SE |
| K960800 | Cedia Red Blood Cell Folate (No Boil Reagent Pack)CGN · Traditional | 07/26/1996SE |
| K962575 | Elecsys Precicontrol CardiacJJY · Traditional | 07/22/1996SE |
| K962573 | Elecsys Precicontrol TSHJJX · Traditional | 07/22/1996SE |
| K961491 | Elecsys TSH AssayJLW · Traditional | 07/22/1996SE |
| K961462 | Cedia Theophylline AssayKLS · Traditional | 06/27/1996SE |
| K961481 | Elecsys 2010 AnalyzerJJE · Traditional | 06/14/1996SE |
| K961659 | Cedia Core TDM Multi-CalJIX · Traditional | 06/13/1996SE |
| K961490 | Elecsys T4 AssayCDX · Traditional | 06/13/1996SE |
| K961488 | Elecsys T-Uptake AssayKHQ · Traditional | 06/12/1996SE |
| K961487 | Elecsys HCG AssayDHA · Traditional | 06/12/1996SE |
| K961501 | Elecsys Ck-MbJHW · Traditional | 06/11/1996SE |
| K961500 | Elecsys Troponin TMMI · Traditional | 06/11/1996SE |
| K961489 | Elecsys FT4 AssayCEC · Traditional | 06/11/1996SE |
| K944459 | Accu-Chek Instant Plus G-C/Dm Blood Glucose Monitoring SystemCGA · Traditional | 04/17/1996SE |
| K954498 | Frontline OpiatesDJG · Traditional | 03/06/1996SE |
| K954497 | Frontline CannabisLDJ · Traditional | 03/06/1996SE |
| K954496 | Frontline CocaineDIO · Traditional | 03/06/1996SE |
| K944458 | Accu-Chek Instant Plus Choloesterol TestCHH · Traditional | 03/06/1996SE |
| K954833 | Accu-Chek Advantage Test StripsLFR · Traditional | 02/15/1996SE |
| K955868 | Boehringer Mannheim Cardiac T Tropnin TMMI · Traditional | 02/14/1996SE |
| K955908 | Boehringer Mannheim Igm AssayDAO · Traditional | 02/09/1996SE |
| K955907 | Boehringer Mannheim Iga AssayCZP · Traditional | 02/09/1996SE |
| K955906 | Boehringer Mannheim Igg AssayDFZ · Traditional | 02/09/1996SE |
| K954608 | Cedia Dau Multi-Dr Calibrator/Pri, Sec, Inter, HighDKB · Traditional | 12/26/1995SE |
| K954807 | Cedia T Uptake AssayKHQ · Traditional | 12/21/1995SE |
| K952875 | Accu-Chek Alpha Monitor & Accu-Chek Glucose Test StripsCGA · Traditional | 11/21/1995SE |
| K952625 | Coaguchek SystemJPA · Traditional | 11/21/1995SE |
| K952478 | Boehringer Mannheim Cardiac T Troponin T Rapid AssayMMI · Traditional | 11/09/1995SE |
| K954346 | Chemstrip Micral Urine Test StripsJIR · Traditional | 10/26/1995SE |
| K954024 | Chemstrip Criterion Urine AnalyzerKQO · Traditional | 10/23/1995SE |
| K953239 | Boehringer Mannheim/Hitachi 917 AnalyzerJJE · Traditional | 09/25/1995SE |
| K952839 | Boehringer Mannheim Ethyl Alcohol AssayDML · Traditional | 08/24/1995SE |
| K951887 | Advantage Test StripsLFR · Traditional | 08/24/1995SE |
| K951331 | Accusport Lactate Monitoring System Lactate Test Strips Accusport MonitorKHP · Traditional | 08/11/1995SE |
| K952127 | Boehringer Mannheim Cholesterol AssayCHH · Traditional | 07/20/1995SE |
| K942884 | Coaguchek SystemGJS · Traditional | 05/11/1995SE |
| K932950 | Tina-Quant MicroalbuminJIR · Traditional | 02/10/1995SE |
| K933461 | Boehringer Mannheim Bicarbonate AssayKHS · Traditional | 12/05/1994SE |
| K943592 | Chemstrip Mini Ua Urine AnalyzerKQO · Traditional | 11/08/1994SE |
| K934070 | Tina-Quant Hemoglobin A1CLCP · Traditional | 10/11/1994SE |
| K942364 | Hitachi 914 AnalyzerJJE · Traditional | 10/04/1994SE |
| K924392 | Cardiac T Elisa Troponin-TMMI · Traditional | 04/26/1994SE |
| K931258 | Softtouch II Lancet DeviceFMK · Traditional | 02/10/1994SE |
| K934064 | Reflotron Hemoglobin Test TabsKHG · Traditional | 12/06/1993SE |
| K932778 | Boehringer Mannheim Es 300 Al(Autoloader) AnalyzerJJQ · Traditional | 11/17/1993SE |
| K933589 | Boehringer Mannheim Tina-Quant Transferrin AssayDDG · Traditional | 11/03/1993SE |
| K934042 | Chemstrip Super Ua Urine AnalyzerKQO · Traditional | 10/14/1993SE |
| K930979 | Accu-Chek Advantage Blood Glucose SystemCGA · Traditional | 09/08/1993SE |
| K930454 | Boehringer Mannheim Coaguchek SystemJPA · Traditional | 08/05/1993SE |
| K931602 | Chemstrip Urine AnalyzerKQO · Traditional | 06/15/1993SE |
| K930621 | Tina-Quant CRPDCK · Traditional | 03/10/1993SE |
| K923048 | Accu-Chek Easy Blood Glucose SystemCGA · Traditional | 10/14/1992SE |
| K924475 | Accudata Glucose Test StationCGA · Traditional | 10/13/1992SE |
| K921661 | Boehringer Mannheim/ Hitachi 911 AnalyzerJJE · Traditional | 06/30/1992SE |
| K921087 | Chemstrip Urine AnalyzerKQO · Traditional | 03/24/1992SE |
| K915195 | Enzymun-Test TSHJLW · Traditional | 02/14/1992SE |
| K915194 | Cedia T4KLI · Traditional | 12/09/1991SE |
| K913614 | Fructosamine ABG21 Test SystemLCP · Traditional | 12/02/1991SE |
| K913162 | Enzymun-Test EstradiolCHP · Traditional | 09/27/1991SE |
| K913615 | Urinary/Csf ProteinJGQ · Traditional | 09/13/1991SE |
| K912212 | Proact Cholesterol SystemsCHH · Traditional | 08/28/1991SE |
| K913105 | Reflotron Creatinine Test TabsJFY · Traditional | 08/12/1991SE |
| K912648 | Ise/Na+JGS · Traditional | 07/17/1991SE |
| K912647 | Ise/Ci-CGZ · Traditional | 07/17/1991SE |
| K912441 | Linearity Test KitsJJY · Traditional | 07/17/1991SE |
| K912649 | Ise/K+CEM · Traditional | 07/15/1991SE |
| K904752 | Chemstrip(R) Micral(Tm) Urine Test StripsJIR · Traditional | 04/12/1991SE |
| K910683 | Enzymun-Test ProgesteroneJLS · Traditional | 04/08/1991SE |
| K904033 | Reflotron Potassium Test TabsCEJ · Traditional | 11/06/1990SE |
| K904292 | Accu-Chek(R) III Blood Glucose SystemCGA · Traditional | 10/22/1990SE |
| K904168 | Accu-Chek (R) Easy (TM) Blood Glucose SystemCGA · Traditional | 10/15/1990SE |
| K904102 | Reflotron Creatine Kinase Test TabsCGS · Traditional | 09/27/1990SE |
| K903573 | Reflotron Creatinine Test TabsJFY · Traditional | 09/07/1990SE |
| K902220 | Precipath(R) Im Normal & Abnormal Immuno. ControlDGR · Traditional | 09/05/1990SE |
| K903194 | Reditest Strep a Test KitGTZ · Traditional | 08/22/1990SE |
| K902569 | Precinorm HDL Cholesterol Control Material for RefJJX · Traditional | 08/09/1990SE |
| K902568 | Reflotron HDL Cholesterol Test TabsLBR · Traditional | 08/09/1990SE |
| K902573 | Precipath(R) Im Abnormal Immunassay Control SerumJJY · Traditional | 07/10/1990SE |
| K902536 | Precinorm(R) Im Normal Immunoassay Control SerumJJY · Traditional | 07/10/1990SE |
| K901216 | Enzymun Test(R) DigoxinKXT · Traditional | 05/31/1990SE |
| K900883 | Enzymun Test(R) FT4 (Free Thyroxine)CEC · Traditional | 05/15/1990SE |
| K900485 | Enzymun Test(R) CortisolCGR · Traditional | 05/02/1990SE |
| K901346 | Es 300 Immunoassay SystemJJE · Traditional | 04/16/1990SE |
| K901003 | Boehringer Mannheim/Hitachi 747 Chemistry AnalyzerJJE · Traditional | 04/16/1990SE |
| K900277 | Enzymun Test(R) Tsh-SJLW · Traditional | 04/11/1990SE |
| K901135 | Enzymun Test(R) InsulinCFP · Traditional | 04/03/1990SE |
| K900779 | Enzymun Test(R) LHCEP · Traditional | 04/03/1990SE |
| K901086 | Enzymun Test(R) T4 (Total Thyroxine)KLT · Traditional | 03/30/1990SE |
| K900695 | Enzymun Test(R) ProlactinCFT · Traditional | 03/30/1990SE |
| K900763 | Enzymun Test(R) FSHCGJ · Traditional | 03/15/1990SE |
| K896991 | Enzymun Test(R) TBKCEE · Traditional | 03/01/1990SE |
| K896901 | Enzymun Test R HCGJHI · Traditional | 02/08/1990SE |
| K896900 | Enzymun Test R T3CDP · Traditional | 02/08/1990SE |
| K900107 | LD-1DET · Traditional | 01/18/1990SE |
| K896454 | Chemstrip(R) 10 with SG Urine Test StripsJIL · Traditional | 01/11/1990SE |
| K896902 | Enzymun Test R IgeDHB · Traditional | 01/10/1990SE |
| K895880 | Pancreatic A-Amylase EpsCIL · Traditional | 12/19/1989SE |
| K895666 | Bun (Kinetic)CDQ · Traditional | 10/27/1989SE |
| K895665 | Uric Acid PapKNK · Traditional | 10/23/1989SE |
| K894207 | CK-MB/LD-1 Control SystemJJT · Traditional | 08/28/1989SE |
| K892848 | Pancreatic A-Amylase PNPJFJ · Traditional | 07/20/1989SE |
| K892838 | Iron System Pack ReagentsJIY · Traditional | 06/16/1989SE |
| K891991 | Bicarbonate; System Pack ReagentsKHS · Traditional | 06/09/1989SE |
| K882225 | -Amylase EpsCIJ · Traditional | 01/03/1989SE |
| K883817 | Accuchek II Freedom(Tm) Monitoring SystemCGA · Traditional | 12/09/1988SE |
| K881908 | Tracer(Tm) II Blood Glucose SystemCGA · Traditional | 07/12/1988SE |
| K881677 | Bun (Kinetic)CDQ · Traditional | 06/07/1988SE |
| K880610 | Unimeter Calibration KitJIW · Traditional | 03/24/1988SE |
| K880546 | Total Iron Binding Capacity (Tibc)JMO · Traditional | 03/24/1988SE |
| K874835 | PYRIDOXAL-5-PHOSPHATE TabletsCKA · Traditional | 01/21/1988SE |
| K874704 | Reflotron (R) AmylaseJFJ · Traditional | 01/05/1988SE |
| K874435 | BicarbonateKHS · Traditional | 11/23/1987SE |
| K874230 | Precinorm LJJY · Traditional | 11/23/1987SE |
| K872818 | Reflotron BilirubinCIG · Traditional | 11/23/1987SE |
| K873363 | Uric Acid PapKNK · Traditional | 10/19/1987SE |
| K873049 | Triglycerides Gpo Without Free GlycerolCDT · Traditional | 08/28/1987SE |
| K872306 | System Pack for B.M.D/Hitachi 704 Chem. Ana.(Gaba)CIC · Traditional | 08/18/1987SE |
| K872494 | Hitachi 717 Chemistry AnalyzerJJE · Traditional | 07/09/1987SE |
| K871896 | Tina-Quant [A] TransferrinDDG · Traditional | 06/15/1987SE |
| K871895 | Tina-Quant [A] CRPDCK · Traditional | 06/15/1987SE |
| K871811 | System Reagents Hitachi 737 Calcium (Edta)CIC · Traditional | 05/26/1987SE |
| K871027 | Precinorm(R) ProteinDAF · Traditional | 05/15/1987SE |
| K871024 | Precimat(R) C3CZW · Traditional | 05/15/1987SE |
| K871023 | Precimat(R) C4DBI · Traditional | 05/14/1987SE |
| K871022 | Precimat(R) TransferrinDDG · Traditional | 05/14/1987SE |
| K871055 | Precimat(R) CRPDCK · Traditional | 05/06/1987SE |
| K863481 | Modification of Accu-Chek IICGA · Traditional | 04/07/1987SE |
| K870931 | Tina-Quant(R) (a) C4DBI · Traditional | 03/24/1987SE |
| K870930 | Tina-Quant(R) (a) C3CZM · Traditional | 03/24/1987SE |
| K870379 | Ise Compensation SeraJIS · Traditional | 02/26/1987SE |
| K870246 | Reflotron(R) Ast (Got)CIT · Traditional | 02/18/1987SE |
| K860948 | Tracker SystemCGA · Traditional | 12/08/1986SE |
| K864082 | Reflotron(R) Alt (GPT)CKD · Traditional | 12/04/1986SE |
| K863822 | Enzymun-Test(R) IgeDGC · Traditional | 10/29/1986SE |
| K863352 | Precimat (R) Iga, G, MCZP · Traditional | 09/17/1986SE |
| K862762 | Tina-Quant(R) IgmDFT · Traditional | 09/08/1986SE |
| K862763 | Tina-Quant(R) IgaCZP · Traditional | 09/04/1986SE |
| K862764 | Tina-Quant(R) IggDEW · Traditional | 09/03/1986SE |
| K862108 | Enzymun-Test HCGDHA · Traditional | 08/19/1986SE |
| K861792 | Twin Got-Ast Ifcc/Gpt-Alt IfccCKA · Traditional | 07/29/1986SE |
| K861831 | Reflotron Uric AcidKNK · Traditional | 07/11/1986SE |
| K861696 | Electrolyte Analyzer Accessory for Hitachi 704JGS · Traditional | 07/01/1986SE |
| K862109 | Enzymun Test TBGCEE · Traditional | 06/30/1986SE |
| K861793 | Twin Triglycerides Gpo/CholesterolCDT · Traditional | 06/27/1986SE |
| K861775 | Twin Bun/GlucoseCDW · Traditional | 06/27/1986SE |
| K860748 | Hitachi 736JJE · Traditional | 04/17/1986SE |
| K860647 | ES600 Immunoassay SystemJJE · Traditional | 04/17/1986SE |
| K860970 | Precinorm Im and Precipath ImJJY · Traditional | 04/03/1986SE |
| K860137 | Enzymun-Test FerritinDBF · Traditional | 03/28/1986SE |
| K855225 | Accu-Chek II Low and High Glucose ControlJJX · Traditional | 01/17/1986SE |
| K854766 | Creatinine PapJFY · Traditional | 01/17/1986SE |
| K854243 | Es 22JJE · Traditional | 11/19/1985SE |
| K854298 | IronCEM · Traditional | 11/12/1985SE |
| K854025 | Hitachi 704JJE · Traditional | 10/28/1985SE |
| K852133 | Reflotron SystemJJE · Traditional | 09/16/1985SE |
| K851456 | Accu-Chek IICGA · Traditional | 08/01/1985SE |
| K852136 | Precinorm HBGGM · Traditional | 07/05/1985SE |
| K850348 | Urotron RL9JJQ · Traditional | 03/12/1985SE |
| K850667 | Peridochrom Triglycerides GpoCDT · Traditional | 03/11/1985SE |
| K850017 | Precinorm H & Precipath HJJY · Traditional | 03/05/1985SE |
| K850281 | CalciumCIC · Traditional | 02/06/1985SE |
| K844655 | Peridochrom Cholesterol High PerformanceCHH · Traditional | 01/07/1985SE |
| K844426 | Albumin BCPCJW · Traditional | 01/07/1985SE |
| K844581 | 80 Mg/Dl Glucose ControlJIS · Traditional | 12/12/1984SE |
| K843283 | Boehringer Mannheim Diagnostics AdamJJE · Traditional | 10/05/1984SE |
| K843569 | Preciset AmmoniaJJX · Traditional | 09/28/1984SE |
| K843088 | Eba 3 S CentrifugeJQC · Traditional | 08/29/1984SE |
| K843087 | Universal 2 S CentrifugeJQC · Traditional | 08/29/1984SE |
| K842393 | Boehringer Mannheim Diag. Blood GlucoseCGA · Traditional | 08/16/1984SE |
| K840962 | Reflocheck-SCGA · Traditional | 06/22/1984SE |
| K834271 | Reflocheck & Glucose Test Strip SysCGA · Traditional | 02/13/1984SE |
| K833082 | Reagent Set Triglycerides GpoCDT · Traditional | 11/25/1983SE |
| K833088 | Spirometer Isolation Valve #8890CAI · Traditional | 10/28/1983SE |
| K832251 | Preciset Cholesterol High PerformJIS · Traditional | 08/24/1983SE |
| K832158 | Cholesterol High Performance-KCHH · Traditional | 08/16/1983SE |
| K830356 | Titanium M.E. Muller Type Total HipJDI · Traditional | 03/09/1983SE |
| K823462 | Single Vial Amylase PNP TestJFJ · Traditional | 12/28/1982SE |
| K823302 | Cholesterol Chod-Pap TestCHH · Traditional | 12/09/1982SE |
| K823196 | Special Control Serum for Hdl-CholesJJK · Traditional | 11/29/1982SE |
| K823213 | Diagnostics Alkaline Phosphatase OptimiCJE · Traditional | 11/22/1982SE |
| K823087 | Boehringer Manneheim Diag. Acid PhosphaCKB · Traditional | 11/18/1982SE |
| K822441 | Unimeter 330KCEM · Traditional | 10/08/1982SE |
| K822445 | HCT CentrifugeGKG · Traditional | 09/14/1982SE |
| K821852 | Diagnostics HDL Cholesterol Precipitant · Traditional | 07/02/1982SE |
| K821805 | PYRIDOXAL-5-PHOSPHATE StripesCKA · Traditional | 07/02/1982SE |
| K820888 | 8700 Clinical Chem. AnalyzerJJE · Traditional | 05/14/1982SE |
| K820596 | Cyanmethemoglobin TestKHG · Traditional | 03/26/1982SE |
| K820378 | Ld-L Tris System Pack TestCFJ · Traditional | 03/08/1982SE |
| K820118 | Electrolyte Analyzer AccessoryJJE · Traditional | 02/04/1982SE |
| K812978 | Uric Acid System Pack TestKNK · Traditional | 11/06/1981SE |
| K812303 | Glucose-Hk System Pack TestCFR · Traditional | 09/01/1981SE |
| K812290 | Fun-Uv System Pack TestCDQ · Traditional | 08/31/1981SE |
| K812095 | Enxymatic Creatinine TestJFY · Traditional | 08/31/1981SE |
| K811921 | Hitachi 705 CalibratorJIX · Traditional | 07/23/1981SE |
| K811832 | Precinorm U & Precipath U Human SerumJJX · Traditional | 07/15/1981SE |
| K811553 | Reagent Set TriglyceridesCHI · Traditional | 06/18/1981SE |
| K811194 | Hitachi 705 Automatic Blood ChemistryJJE · Traditional | 05/27/1981SE |
| K810964 | Bio Set TM Phosphorous CalibratorJIX · Traditional | 04/17/1981SE |
PMA approvals
- P820073 Micur-Mic Systems · 06/29/1983 · 0 supplements