FDA applicant

First Check Diagnostics, LLC

Lake Forest, CA1 decision2005–200586 recalls

FDA records 1 decision for First Check Diagnostics, LLC (Lake Forest, CA) in 2005: 1 510(k) clearance. All are in product code DKZ (Enzyme Immunoassay, Amphetamine). Its devices cite 1 predicate, 0 of them its own earlier devices. 86 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 toxicology panel, where it files most

How often FDA has decided First Check Diagnostics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for First Check Diagnostics, LLC since 2007.

Recalls per year

7in 2020

2007high 78 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — First Check Diagnostics, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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First Check Diagnostics, LLC

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?

What has been recalled?