# Bayer Corp.

- Location (FDA's records): Tarrytown, NY
- FDA decisions: 96 (1989–2003): 96 510(k) clearances
- Product codes: CGA (8), JIR (4), LTJ (4), MMI (4), NBW (3), LFX (3), LTK (3), GKZ (3), LGD (3), CFR (3), NCW (2), KLT (2)
- Predicates its devices cite: 12 (4 its own); citations of its devices by later devices: 70 (4 its own)
- Recalls linked to its devices: 36 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bayer Group Diagnostics: 1 (https://510kreport.com/company/bayer-group-diagnostics)
- Brahms Diagnostica, LLC: 1 (https://510kreport.com/company/brahms-diagnostica)
- Dade Behring, Inc.: 1 (https://510kreport.com/company/dade-behring)
- Abbott Vascular: 1 (https://510kreport.com/company/abbott-vascular)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Chiron Diagnostics Corp.: 1 (https://510kreport.com/company/chiron-diagnostics)
- Miles Laboratories, Inc.: 1 (https://510kreport.com/company/miles-laboratories)
- Ciba Corning Diagnostics Corp.: 1 (https://510kreport.com/company/ciba-corning-diagnostics)

## Firms that cite its devices most
- Bayer Healthcare, LLC: 11 (https://510kreport.com/company/bayer-healthcare)
- Siemens Healthcare Diagnostics, Inc.: 8 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Thermofisher Scientific OY: 5 (https://510kreport.com/company/thermofisher-scientific)
- Bayer Diagnostics Corp.: 4 (https://510kreport.com/company/bayer-diagnostics)
- Siemens Medical Solutions Diagnostics: 3 (https://510kreport.com/company/siemens-medical-solutions-diagnostics)
- Vip Diagnostics, LLC: 3 (https://510kreport.com/company/vip-diagnostics)
- Randox Laboratories, Ltd.: 2 (https://510kreport.com/company/randox-laboratories)
- Selfcare, Inc.: 2 (https://510kreport.com/company/selfcare)

## Its most-cited devices
- K991576: Additional Assays for the Bayer Advia 1650 Chemistry System (1999), cited by 12
- K960546: Clinitek 50 Urine Chemistry Analyzer (1996), cited by 6
- K964630: Glucometer Elite Blood Glucose Meter (1997), cited by 6
- K992257: New Multiples Reagent Strips (1999), cited by 4
- K991242: Glucometer Elite Test Strips (1999), cited by 3
- K972706: Clinitek Microalbumin Reagent Strips (1997), cited by 3

## Recent decisions
- K024062: Ascensia Breeze Blood Glucose Meter (Mar 3, 2003)
- K023944: Bayer Diagnostics Clinitest Pregnancy Test (Feb 11, 2003)
- K024017: Bayer Advia Centaur Her-2/Neu Assay (Jan 30, 2003)
- K024234: Ascensia Glucofacts; Ascensia Glucofacts Professional (Jan 23, 2003)
- K022288: Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module System (Dec 17, 2002)
- K023584: Ascensia Dex 2 Diabetes Care System (Nov 20, 2002)
- K020828: CA 125 Assay for the Advia Centaur System (Jul 24, 2002)
- K021428: Clinitek Atlas Pro 12 Reagent Pak System (Jul 5, 2002)

Source page: https://510kreport.com/company/bayer