510(k) Report

FDA applicant

Bio-Rad Laboratories, Inc., Clinical Systems Divis

Hercules, CA3 decisions2012–20130 recalls

FDA records 3 decisions for Bio-Rad Laboratories, Inc., Clinical Systems Divis (Hercules, CA) from 2012 to 2013: 3 510(k) clearances. All are in product code LCP (Assay, Glycosylated Hemoglobin). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is 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 Divis’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2012: 12013: 2
2012high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Bio-Rad Laboratories, Inc., Clinical Systems Divis by year, 2012–2026Sources: 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 Hemoglobin3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K122472Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing SystemBio-Rad Laboratories, Inc., Clinical Systems Divis · 20121cites it

What has FDA decided for it lately?

  • K130990Variant (TM) II Turbo HBA1C Kit - 2.0Bio-Rad Laboratories, Inc., Clinical Systems Divis · 2013
  • K130860Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with CDM Software, CDM SoftwareBio-Rad Laboratories, Inc., Clinical Systems Divis · 2013
  • K122472Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing SystemBio-Rad Laboratories, Inc., Clinical Systems Divis · 2012

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