# Bio-Rad

- Location (FDA's records): Irvine, CA
- FDA decisions: 320 (1976–2017): 319 510(k) clearances and 1 original PMA approval
- Product codes: JJY (61), DIF (31), JJX (21), LCP (15), DHN (14), JJS (9), LKJ (9), JLW (9), GGN (7), JSO (6), JJT (6), JJW (5)
- Predicates its devices cite: 136 (63 its own); citations of its devices by later devices: 171 (63 its own)
- Recalls linked to its devices: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Casco Standards: 16 (https://510kreport.com/company/casco-standards)
- Kallestad Laboratories, Inc.: 13 (https://510kreport.com/company/kallestad-laboratories)
- Helix Diagnostics, Inc.: 8 (https://510kreport.com/company/helix-diagnostics)
- Ciba Corning Diagnostics Corp.: 3 (https://510kreport.com/company/ciba-corning-diagnostics)
- Axis Biochemicals, Asa: 3 (https://510kreport.com/company/axis-biochemicals)
- Bio-Rad Laboratories, Inc.: 2 (https://510kreport.com/company/bio-rad-laboratories)
- Helena Laboratories: 2 (https://510kreport.com/company/helena-laboratories)
- Hematronix, Inc.: 2 (https://510kreport.com/company/hematronix)

## Firms that cite its devices most
- Bio-Rad Laboratories, Inc.: 33 (https://510kreport.com/company/bio-rad-laboratories)
- Ortho-Clinical Diagnostics, Inc.: 12 (https://510kreport.com/company/ortho-clinical-diagnostics)
- Biosite Incorporated: 7 (https://510kreport.com/company/biosite)
- Maine Standards Co.: 3 (https://510kreport.com/company/maine-standards)
- bioMerieux, Inc.: 3 (https://510kreport.com/company/biomerieux)
- Techno-Path Manufacturing, Ltd.: 3 (https://510kreport.com/company/techno-path-manufacturing)
- Bio-Rad Laboratories Inc., Clinical Systems Divisi: 3 (https://510kreport.com/company/bio-rad-laboratories-clinical-systems-divisi)
- Seracare Technology: 2 (https://510kreport.com/company/seracare-technology)

## Its most-cited devices
- K022707: Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439 (2002), cited by 10
- K984268: Variant II Hemoglobin A1C Program (1998), cited by 6
- K961828: Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688) (1996), cited by 6
- K981532: Lyphochek Immunoassay Plus Control (1998), cited by 6
- K050537: Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT, Liquichek Cardiac Markers Plus (2005), cited by 6
- K935286: Quantaphase II B12/Folate (1994), cited by 5

## Recent decisions
- K171061: MRSASelect II (Dec 28, 2017)
- K122187: Vreselect Culture Medium (Nov 6, 2012)
- K103684: Vreselect Culture Medium (Oct 21, 2011)
- K093678: Platelia Aspergillus Eia Model 62793 (Jan 13, 2011)
- K100589: Mrsa Select - Skin and Soft Tissue Wound Specimens (Oct 29, 2010)
- K081362: Platelia Lyme Igm (Jun 26, 2008)
- K081212: Mrsaselect - Extended Incubation (Jun 13, 2008)
- K080012: Platelia Lyme Igg Assay (May 8, 2008)

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