# Bio-Rad Laboratories Inc., Clinical Systems Divisi

- Location (FDA's records): Hercules, CA
- FDA decisions: 3 (2006–2008): 3 510(k) clearances
- Product codes: LCP (2), GKA (1)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bio-Rad Laboratories, Inc.: 3 (https://510kreport.com/company/bio-rad-laboratories)
- Bio-Rad: 3 (https://510kreport.com/company/bio-rad)

## Firms that cite its devices most
- Bio-Rad Laboratories, Inc.: 2 (https://510kreport.com/company/bio-rad-laboratories)
- Bio-Rad Laboratories, Inc., Clinical Systems Divis: 1 (https://510kreport.com/company/bio-rad-laboratories-clinical-systems-divis)

## Its most-cited devices
- K070819: Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin Testing with Model, 270-2716, (2007), cited by 1
- K063643: Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total GHB Program (2006), cited by 1
- K080911: Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and Variant NBS Workstation with (2008), cited by 1

## Recent decisions
- K080911: Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and Variant NBS Workstation with (May 2, 2008)
- K070819: Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin Testing with Model, 270-2716, (Jun 25, 2007)
- K063643: Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total GHB Program (Dec 27, 2006)

Source page: https://510kreport.com/company/bio-rad-laboratories-clinical-systems-divisi