FDA applicant

Bio-Rad, Diagnostics Grp.

Irvine, CA6 decisions2007–20120 recalls

FDA records 6 decisions for Bio-Rad, Diagnostics Grp. (Irvine, CA) from 2007 to 2012: 6 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and GGN (Plasma, Coagulation Control). Its devices cite 6 predicates, 0 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, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2012

2007high 4 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Bio-Rad, Diagnostics Grp.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?