510(k) Report

FDA applicant

Bio-Rad Laboratories Inc., Clinical Systems Divisi

Hercules, CA3 decisions2006–20086 recalls

FDA records 3 decisions for Bio-Rad Laboratories Inc., Clinical Systems Divisi (Hercules, CA) from 2006 to 2008: 3 510(k) clearances. Most are in product codes LCP (Assay, Glycosylated Hemoglobin) and GKA (Abnormal Hemoglobin Quantitation). Its devices cite 6 predicates, 0 of them its own earlier devices. 6 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, hematology panel, where it files most

How often FDA has decided Bio-Rad Laboratories Inc., Clinical Systems Divisi’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

4in 2011

2008: 12010: 12011: 4
2007high 4 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Bio-Rad Laboratories Inc., Clinical Systems Divisi 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?

  • LCPAssay, Glycosylated Hemoglobin2decisions
  • GKAAbnormal Hemoglobin Quantitation1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K070819Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin Testing with Model…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 20071cites it
  • K063643Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total GHB ProgramBio-Rad Laboratories Inc., Clinical Systems Divisi · 20061cites it
  • K080911Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and Variant NBS…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 20081cites it

What has FDA decided for it lately?

  • K080911Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and Variant NBS…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 2008
  • K070819Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin Testing with Model…Bio-Rad Laboratories Inc., Clinical Systems Divisi · 20075 recalls
  • K063643Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total GHB ProgramBio-Rad Laboratories Inc., Clinical Systems Divisi · 20061 recall

All 3 as Bio-Rad Laboratories Inc., Clinical Systems Divisi →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K070819VARIANT II Link Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, For the…Oct 25, 2011
  • K070819VARIANT II TURBO LINK Hemoglobin A1c Program Reorder Pack, 1600 tests. For the…Sep 12, 2011
  • K070819VARIANT II TURBO LINK Hemoglobin A1c Program Buffer Set. Made in United States. Bio-Rad…Sep 12, 2011
  • K070819VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack. Calibrator/Diluent Set. IVD.…Jul 28, 2011
  • K070819Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program…Feb 19, 2010
  • K063643Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000…Dec 9, 2008