Baxter Diagnostics, Inc.
Medical device manufacturer in West Sacramento, CA.
72510(k) clearances
0PMA approvals
0recalls
Device types
- JWY Manual Antimicrobial Susceptibility Test… 12
- JJY Multi-Analyte Controls, All Kinds (Assayed) 5
- LGC Enzyme Linked Immunoabsorbent Assay, Herpes… 4
- LTT Panels, Test, Susceptibility, Antimicrobial 3
- LFX Enzyme Linked Immunoabsorbent Assay, Rubella 2
- LGD Enzyme Linked Immunoabsorbent Assay… 2
- LKT Respiratory Syncytial Virus, Antigen… 2
- GQS Antigens, Cf (Including Cf Control)… 2
- DDR Myoglobin, Antigen, Antiserum, Control 2
- GJS Test, Time, Prothrombin 2
- JLS Radioimmunoassay, Progesterone 2
- LJB Enzyme Linked Immunoabsorbent Assay… 2
- GNX Antigens, Cf (Including Cf Control)… 1
- LJC Enzyme Linked Immunoabsorbent Assay… 1
- LSE Epstein-Barr Virus, Other 1
- JMO Ferrozine (Colorimetric) Iron Binding… 1
- MIF Prothrombin Fragment 1.2 1
- GJT Plasma, Coagulation Factor Deficient 1
- GGP Test, Qualitative And Quantitative Factor… 1
- JJQ Colorimeter, Photometer, Spectrophotometer… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K934458 | Dried Gram-Positive Mic/Combo PanelsJWY · Traditional | 07/18/1995SE |
| K950817 | Dried Gram Positive Mic/Combo Panels/PneumococciJWY · Traditional | 04/25/1995SE |
| K935704 | Dried Gram-Negative Mic//Combo PanelsLTT · Traditional | 04/14/1995SE |
| K950570 | Stratus Progesterone Fluorometric Enzyme ImmunoassayJLS · Traditional | 04/11/1995SE |
| K945235 | Dried Gram-Positive Mic/Combo PanelsLTT · Traditional | 03/07/1995SE |
| K941030 | Dried Gram-Negative CefpodoximeLTT · Traditional | 02/16/1995SE |
| K940917 | Loracarbef Gram-Nagative PanelsJWY · Traditional | 02/08/1995SE |
| K941459 | Gram Positive Dried Overnight Panels/LomefloxJWY · Traditional | 02/03/1995SE |
| K941317 | Dried Gram Negative/CefmetazoleJWY · Traditional | 01/31/1995SE |
| K942267 | Dried Gram-Positive Mic/Combo Panels/CefmetazoleJWY · Traditional | 01/09/1995SE |
| K942089 | Microdilution/Loracarbef PanelsJWY · Traditional | 01/09/1995SE |
| K943510 | Dried Gram-Positive Mic/Combo PanelsJWY · Traditional | 12/02/1994SE |
| K935702 | Dade Innovin IIGJS · Traditional | 11/22/1994SE |
| K935307 | Dade(R) Thrombin-Antithrombin (Tat) Complex ElisaDDQ · Traditional | 11/22/1994SE |
| K934003 | Stratus Digoxin Flourometric Enzyme ImmunoassayDKA · Traditional | 11/22/1994SE |
| K933414 | Stratus(R) Thyroid Uptake Fluor Enzyme ImmunoassayKHQ · Traditional | 11/22/1994SE |
| K944651 | Dried Gram-Positive Mic/Combo PanelsJWY · Traditional | 11/18/1994SE |
| K934323 | Dried Gram-Positive Mic/Combo Panels, Amp/Ext DilJWY · Traditional | 10/19/1994SE |
| K935987 | FlextransJSM · Traditional | 08/15/1994SE |
| K936196 | Antithrombin III Chromogenic AssayJBQ · Traditional | 05/04/1994SE |
| K934275 | Paramax Alcohol ReagentDIC · Traditional | 04/26/1994SE |
| K935568 | Paramax Phenobarbital Reagent and CalibratorsDLZ · Traditional | 03/11/1994SE |
| K932686 | Paramax(R) Phenytoin ReagentDIP · Traditional | 11/26/1993SE |
| K933437 | Dade Anemia/Hemochromatosis Contols,Level 1,LEVEL 2,AND Level 3JJY · Traditional | 10/28/1993SE |
| K932912 | Stratus Free Thyroxine (Free T4) FluorometricCEC · Traditional | 10/28/1993SE |
| K933464 | Stratus Estradiol Fluorometric Enzyme ImmunoassayCHP · Traditional | 10/22/1993SE |
| K933635 | Stratus Progesterone Flourometric ImmunoassayJLS · Traditional | 10/08/1993SE |
| K933435 | Dade Urine Chemistry Control, Level 1 & Level 2JJY · Traditional | 09/24/1993SE |
| K932685 | Paramax(R) Theophylline Reagent and CalibratorsKLS · Traditional | 09/24/1993SE |
| K933188 | Dade (PAI-1) Chromogenic Assay Dade Coagtrol-PaiJPA · Traditional | 09/22/1993SE |
| K933426 | Stratus(R) Total THYROXINE(T4) Fluor Enzyme ImmunoCDX · Traditional | 08/26/1993SE |
| K924919 | Dade(R) Tumor Marker ControlJJY · Traditional | 08/05/1993SE |
| K932082 | Dried Gram-Negative Mic/Combo PanelsJWY · Traditional | 07/20/1993SE |
| K922582 | Bartels Cytomegalovirus Igg EiaLFZ · Traditional | 04/08/1993SE |
| K922580 | Bartels Cytomegalovirus Igm EiaLKQ · Traditional | 04/08/1993SE |
| K926545 | Dried Gram-Negative Mic/Combo PanelsJWY · Traditional | 03/26/1993SE |
| K922482 | Microscan Dri Gram Posit/Gram Nega Mic/Combo PanelLRG · Traditional | 03/12/1993SE |
| K925452 | Dade HepzymeJBR · Traditional | 01/11/1993SE |
| K926046 | Dade(R) Ck-Mb/Myoglobin Immun Control, I,Ii,IiiJJY · Traditional | 01/05/1993SE |
| K922334 | Bartels Herpes Simplex Virus 1 Igm EiaLGC · Traditional | 12/15/1992SE |
| K922333 | Bartels Herpes Simplex Virus 2 Igm EiaLGC · Traditional | 12/15/1992SE |
| K924074 | Stratus Vitamin B12 Fluorometric Enzyme-LinkedCDD · Traditional | 10/26/1992SE |
| K922073 | Stratus BHCG Fluorometric Enzyme ImmunoassayDHA · Traditional | 10/19/1992SE |
| K922583 | Bartels Herpes Simplex Virus 2 Igg EiaLGC · Traditional | 09/28/1992SE |
| K922584 | Bartels Herpes Simplex Virus 1 Igg EiaLGC · Traditional | 09/18/1992SE |
| K923286 | Stratus Folate Fluorometric Enzyme-Linked AssayCGN · Traditional | 09/17/1992SE |
| K922586 | Bartels Rubella Igg EiaLFX · Traditional | 09/17/1992SE |
| K922581 | Bartels Rubella Igm EiaLFX · Traditional | 09/17/1992SE |
| K922585 | Bartels Toxoplasma Igg EiaLGD · Traditional | 09/02/1992SE |
| K922579 | Bartels Toxoplasma Igm EiaLGD · Traditional | 09/02/1992SE |
| K922578 | Bartels Lyme Disease Igm EiaLSR · Traditional | 09/02/1992SE |
| K922335 | Bartels Rubeola Igm EiaLJB · Traditional | 09/02/1992SE |
| K922332 | Bartels Epstein-Barr Virus Igg EiaLSE · Traditional | 09/02/1992SE |
| K922331 | Bartels Epstein-Barr Virus Igm EiaLJN · Traditional | 09/02/1992SE |
| K922330 | Bartels Rubeola Igg EiaLJB · Traditional | 09/02/1992SE |
| K923569 | Paramax Total Iron Binding Capacity PretreatmentJMO · Traditional | 08/26/1992SE |
| K921326 | Dade Recomboplastin SGJS · Traditional | 07/27/1992SE |
| K922125 | Stratus Myoglobin Fluorometric Enzyme ImmunoassayDDR · Traditional | 07/21/1992SE |
| K922387 | Dade(R) Myoglobin Controls Tri-LevelDDR · Traditional | 07/15/1992SE |
| K920636 | Dade Urine Chemistry Control Levels I and IIJJY · Traditional | 07/07/1992SE |
| K920895 | Dade(R) Prothrombin Fragment F1.2 ElisaMIF · Traditional | 06/04/1992SE |
| K921037 | Apolipoprotein Test SystemMSJ · Traditional | 05/22/1992SE |
| K915411 | Dade Immunoadsorbed Factor Ix Deficient PlasmaGJT · Traditional | 05/11/1992SE |
| K914818 | Dade(R) Alpha 2 ANTIPLASMIN(2 2-AP) Chromo AssayGGP · Traditional | 01/15/1992SE |
| K914202 | Bartels Prima System Advanced Screening CartridgeJJQ · Traditional | 10/11/1991SE |
| K912838 | Bartels Respiratory Syncytial Virus Enzyme ImmunoLKT · Traditional | 09/27/1991SE |
| K913229 | Bartels Clostridium Difficile Toxin a Enzym ImmunLLH · Traditional | 08/29/1991SE |
| K912680 | Antigenz ChlamydiaLJC · Traditional | 07/22/1991SE |
| K884194 | Parainfluenza Type 1 Ifa Test Kit for Anti. DetectGQS · Traditional | 11/22/1988SE |
| K884193 | Parainfluenza Type 3 Ifa Test Kit for Anti. DetectGQS · Traditional | 11/22/1988SE |
| K884192 | RSV Ifa Test Kit for Direct Antigen DetectionLKT · Traditional | 11/22/1988SE |
| K884191 | Influenza a Ifa Test for Direct Antigen DetectionGNX · Traditional | 11/22/1988SE |