Company ยท US
Bayer Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2003. Name variants (Inc, Corp, punctuation) are merged.
96510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CGA | Glucose Oxidase, Glucose | 8 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 4 |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | 4 |
| MMI | Immunoassay Method, Troponin Subunit | 4 |
| CFR | Hexokinase, Glucose | 3 |
| GKZ | Counter, Differential Cell | 3 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 3 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 3 |
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 3 |
| NBW | System, Test, Blood Glucose, Over The Counter | 3 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 2 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 2 |
| GKL | Counter, Cell, Automated (Particle Counter) | 2 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 2 |
| KLT | Enzyme Immunoassay, Carbamazepine | 2 |
| LOJ | Kit, Test,Alpha-Fetoprotein For Testicular Cancer | 2 |
| NCW | System, Test, Her-2/Neu, Monitoring | 2 |
| CDD | Radioassay, Vitamin B12 | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 3, 2003 | K024062 | ASCENSIA BREEZE BLOOD GLUCOSE METER Bayer Corp. | CGA |
| Feb 11, 2003 | K023944 | BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST Bayer Corp. | JHI |
| Jan 30, 2003 | K024017 | BAYER ADVIA CENTAUR HER-2/NEU ASSAY Bayer Corp. | NCW |
| Jan 23, 2003 | K024234 | ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL Bayer Corp. | NBW |
| Dec 17, 2002 | K022288 | COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM Bayer Corp. | LTJ |
| Nov 20, 2002 | K023584 | ASCENSIA DEX 2 DIABETES CARE SYSTEM Bayer Corp. | NBW |
| Jul 24, 2002 | K020828 | CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM Bayer Corp. | LTK |
| Jul 5, 2002 | K021428 | CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM Bayer Corp. | JFY |
| Mar 27, 2002 | K020806 | ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY Bayer Corp. | LOJ |
| Dec 21, 2001 | K013568 | CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM Bayer Corp. | DHX |
| Dec 6, 2001 | K012337 | BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM Bayer Corp. | DCN |
| Nov 20, 2001 | K011963 | ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY Bayer Corp. | CFR |
| Oct 25, 2001 | K013272 | ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY Bayer Corp. | KLS |
| Oct 22, 2001 | K012777 | ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS Bayer Corp. | JZO |
| Oct 1, 2001 | K012340 | BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) Bayer Corp. | JMO |
| Sep 12, 2001 | K012205 | GLUCOMETER DEX TEST SENSOR Bayer Corp. | NBW |
| Aug 20, 2001 | K010755 | BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY Bayer Corp. | LGD |
| Jul 5, 2001 | K010668 | BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY Bayer Corp. | LFX |
| Apr 13, 2001 | K003412 | ADVIA CENTAUR RUBELLA IGG ASSAY Bayer Corp. | LFX |
| Mar 29, 2001 | K010201 | BAYER ADVIA IMS SYSTEM Bayer Corp. | MMI |
| Feb 5, 2001 | K003796 | ADVIA 120 HEMATOLOGY Bayer Corp. | GKZ |
| Dec 19, 2000 | K002738 | BAYER RAPIDPOINT 400 SYSTEM Bayer Corp. | CHL |
| Oct 26, 2000 | K002376 | ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY Bayer Corp. | LTJ |
| Sep 29, 2000 | K992228 | BAYER IMMUNO 1 HER-2/NEU ASSAY Bayer Corp. | NCW |
| Jun 26, 2000 | K001344 | ADVIA IMS Bayer Corp. | DIH |
| May 18, 2000 | K000921 | BAYER ADVIA IMS SYSTEM; 200 + 3 Bayer Corp. | DER |
| May 18, 2000 | K000903 | ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM Bayer Corp. | KLT |
| Apr 13, 2000 | K994221 | BAYER PSA ASSAY Bayer Corp. | LTJ |
| Apr 10, 2000 | K993867 | BAYER ADVIA IMS SYSTEM Bayer Corp. | CIG |
| Feb 15, 2000 | K992662 | 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM Bayer Corp. | MSJ |
| Dec 16, 1999 | K993711 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) Bayer Corp. | JZG |
| Dec 16, 1999 | K993571 | BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12 Bayer Corp. | CDD |
| Dec 6, 1999 | K993353 | TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM) Bayer Corp. | MMI |
| Dec 6, 1999 | K993309 | BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY Bayer Corp. | MMI |
| Nov 24, 1999 | K992257 | NEW MULTIPLES REAGENT STRIPS Bayer Corp. | JIR |
| Nov 12, 1999 | K991315 | MICROALBUSTIX REAGENT STRIPS (OTC) Bayer Corp. | JIR |
| Nov 9, 1999 | K992136 | BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) Bayer Corp. | CIT |
| Nov 9, 1999 | K991907 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM Bayer Corp. | CZW |
| Sep 15, 1999 | K992399 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM Bayer Corp. | CIX |
| Jul 22, 1999 | K991817 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM Bayer Corp. | CIJ |
| Jul 9, 1999 | K990649 | GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS Bayer Corp. | CGA |
| Jun 30, 1999 | K991576 | ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM Bayer Corp. | CIX |
| Jun 30, 1999 | K991242 | GLUCOMETER ELITE TEST STRIPS Bayer Corp. | CGA |
| May 21, 1999 | K990346 | BAYER ADVIA 1650 CHEMISTRY SYSTEM Bayer Corp. | JGS |
| May 14, 1999 | K983715 | THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) Bayer Corp. | LTK |
| Mar 18, 1999 | K984006 | GLUCOMETER ELITE XL BLOOD GLUCOSE METER Bayer Corp. | CGA |
| Jan 29, 1999 | K982328 | BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) Bayer Corp. | CJO |
| Dec 7, 1998 | K983345 | BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY Bayer Corp. | JJE |
| Oct 22, 1998 | K982714 | BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY Bayer Corp. | DBF |
| Sep 22, 1998 | K982802 | BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) Bayer Corp. | GKZ |
Newest 50 of 96.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2014 | Bayer Corp Medrad Continuum MR Infusion system- non-wireless system
The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intend Terminated |
FRN | K073051 |
| Oct 24, 2003 | Bayer Corp. Bayer Rapidpoint 405 Blood Gas Analyzer Terminated |
CHL | K020616 |