# Bio-Rad, Diagnostics Grp.

- Location (FDA's records): Irvine, CA
- FDA decisions: 6 (2007–2012): 6 510(k) clearances
- Product codes: JJY (3), GGN (1), JJW (1), DIF (1)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 7 (0 its own)
- Recalls linked to its devices: 0 (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: 2 (https://510kreport.com/company/bio-rad)
- Biopool Intl., Inc.: 1 (https://510kreport.com/company/biopool-intl)

## Firms that cite its devices most
- ACON Laboratories, Inc.: 2 (https://510kreport.com/company/acon-laboratories)
- Techno-Path Manufacturing, Ltd.: 1 (https://510kreport.com/company/techno-path-manufacturing)
- Bio-Rad Laboratories, Inc.: 1 (https://510kreport.com/company/bio-rad-laboratories)
- Randox Laboratories, Ltd.: 1 (https://510kreport.com/company/randox-laboratories)
- Chromsystems Instruments & Chemicals GmbH: 1 (https://510kreport.com/company/chromsystems-instruments-chemicals)
- Horiba Abx: 1 (https://510kreport.com/company/horiba-abx)

## Its most-cited devices
- K070848: Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level 2,Minipak, 435,436,437,435X (2007), cited by 2
- K072835: Liquichek Microalbumin Control Level 1, Level 2, Control Minipak (2007), cited by 2
- K072721: Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCC (2007), cited by 2
- K100727: Liquid Assayed Multiqual 1, Liquid Assayed Multiqual 2, Liquid Assayed Multiqual 3, Liquid Assayed Multiqual Minipak (2010), cited by 1

## Recent decisions
- K121794: Liquichek Urine Chemistry Control (Jul 11, 2012)
- K100727: Liquid Assayed Multiqual 1, Liquid Assayed Multiqual 2, Liquid Assayed Multiqual 3, Liquid Assayed Multiqual Minipak (Sep 14, 2010)
- K072835: Liquichek Microalbumin Control Level 1, Level 2, Control Minipak (Dec 11, 2007)
- K072721: Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCC (Dec 11, 2007)
- K071319: I-Stat Activated Clotting Time (Act) Control Set Level 1 and Level 2, Models 07G82-01, 07G82-02 (Jun 26, 2007)
- K070848: Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level 2,Minipak, 435,436,437,435X (Apr 25, 2007)

Source page: https://510kreport.com/company/bio-rad-diagnostics-grp