510(k) Report

FDA applicant

Bio-Rad

Irvine, CA320 decisions1976–201716 recalls

FDA records 320 decisions for Bio-Rad (Irvine, CA) from 1976 to 2017: 319 510(k) clearances and 1 original PMA approval. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and DIF (Drug Mixture Control Materials). Its devices cite 136 predicates, 63 of them its own earlier devices. 16 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Bio-Rad’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007: 12008: 32010: 12011: 22012: 12017: 1
2007high 3 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

2in 2018

2007: 12008: 52009: 22010: 12011: 32014: 12018: 2
2007high 5 (2008) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Bio-Rad by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JJYMulti-Analyte Controls, All Kinds (Assayed)61decisions
  • DIFDrug Mixture Control Materials31decisions
  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)21decisions
  • LCPAssay, Glycosylated Hemoglobin15decisions
  • DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control14decisions
  • JJSControls For Blood-Gases, (Assayed And Unassayed)9decisions

Also: LKJ (9), JLW (9), GGN (7), JSO (6), JJT (6), JJW (5).

Whose devices does it build on?

Its devices cite 136 predicates; 63 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 171 times; 63 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K022707Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439Bio-Rad · 200210cite it
  • K984268Variant II Hemoglobin A1C ProgramBio-Rad · 19986cite it
  • K961828Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Bio-Rad · 19966cite it
  • K981532Lyphochek Immunoassay Plus ControlBio-Rad · 19986cite it
  • K050537Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT, Liquichek Cardiac Markers…Bio-Rad · 20056cite it
  • K935286Quantaphase II B12/FolateBio-Rad · 19945cite it

What has FDA decided for it lately?

  • K171061MRSASelect IIBio-Rad · 20171 recall
  • K122187Vreselect Culture MediumBio-Rad · 2012
  • K103684Vreselect Culture MediumBio-Rad · 2011
  • K093678Platelia Aspergillus Eia Model 62793Bio-Rad · 2011
  • K100589Mrsa Select - Skin and Soft Tissue Wound SpecimensBio-Rad · 2010
  • K081362Platelia Lyme IgmBio-Rad · 2008
  • K081212Mrsaselect - Extended IncubationBio-Rad · 20081 recall
  • K080012Platelia Lyme Igg AssayBio-Rad · 2008

All 320 as Bio-Rad →

What has been recalled?

16 recalls linked to its devices; the latest:

  • K171061MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for…Jun 8, 2018Class II
  • K081212MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is…Jun 8, 2018Class II
  • K991127Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and…Apr 8, 2014Class II
  • K991127VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and…Sep 12, 2011
  • K924122VARIANT / VARIANT II B-thalassemia Short Program Elution Buffer 2,. Made in United…Sep 12, 2011
  • K991127VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and…Sep 12, 2011