# Bio-Rad Laboratories, Inc.

- Location (FDA's records): Chaska, MN
- FDA decisions: 132 (1984–2019): 127 510(k) clearances, 1 De Novo grant and 4 original PMA approvals
- Names in FDA's records: Bio-Rad Laboratories, Inc. (85); Bio-Rad Laboratories (47)
- Product codes: JJY (26), LCP (8), DIF (5), LOL (4), SEI (3), CDP (3), JJX (3), LIP (3), DHB (3), LJC (3), PDJ (3), LKJ (2)
- Predicates its devices cite: 121 (27 its own); citations of its devices by later devices: 90 (27 its own)
- Recalls linked to its devices: 76 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bio-Rad: 33 (https://510kreport.com/company/bio-rad)
- Inova Diagnostics, Inc.: 11 (https://510kreport.com/company/inova-diagnostics)
- Helix Diagnostics, Inc.: 5 (https://510kreport.com/company/helix-diagnostics)
- Corgenix, Inc.: 4 (https://510kreport.com/company/corgenix)
- Biomerieux Vitek, Inc.: 3 (https://510kreport.com/company/biomerieux-vitek)
- DiaSorin, Inc.: 3 (https://510kreport.com/company/diasorin)
- Bio-Rad Laboratories Inc., Clinical Systems Divisi: 2 (https://510kreport.com/company/bio-rad-laboratories-clinical-systems-divisi)
- Hematronix, Inc.: 2 (https://510kreport.com/company/hematronix)

## Firms that cite its devices most
- Beckman Coulter, Inc.: 18 (https://510kreport.com/company/beckman-coulter)
- Randox Laboratories, Ltd.: 3 (https://510kreport.com/company/randox-laboratories)
- Microgenics Corp.: 3 (https://510kreport.com/company/microgenics)
- Bio-Rad Laboratories Inc., Clinical Systems Divisi: 3 (https://510kreport.com/company/bio-rad-laboratories-clinical-systems-divisi)
- Elitechgroup: 3 (https://510kreport.com/company/elitechgroup)
- Bio-Rad, Diagnostics Grp.: 3 (https://510kreport.com/company/bio-rad-diagnostics-grp)
- Bio-Rad: 2 (https://510kreport.com/company/bio-rad)
- Bio-Rad Laboratories, Inc., Clinical Systems Divis: 2 (https://510kreport.com/company/bio-rad-laboratories-clinical-systems-divis)

## Its most-cited devices
- K020817: Liquichek Urine Chemistry Control (2002), cited by 6
- K070452: Variant II Hemoglobin A1C Program with Models 270-2101NU (2007), cited by 5
- K926221: Access Ferritin Assay (1993), cited by 5
- K151321: D-100 HbA1c, D-100 HbA1c Calibrator Pack (2015), cited by 4
- K022041: Lyphochek Whole Blood Control, Models 561, 562, 563 (2002), cited by 4
- DEN150058: Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak (2016), cited by 4

## Recent decisions
- K183446: BioPlex 2200 Lyme Total (Mar 12, 2019)
- K181661: QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System (Feb 13, 2019)
- K180577: BioPlex 2200 25-OH Vitamin D Kit (Jun 22, 2018)
- K171664: Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software (Sep 13, 2017)
- K170509: BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set (May 19, 2017)
- K170413: BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set (May 11, 2017)
- K163015: Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak (Jan 10, 2017)
- K161687: D-10 Hemoglobin A1c Program (Oct 14, 2016)

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