FDA applicant

Exigent Diagnostics, Inc.

Culver City, CA9 decisions1998–19980 recalls

FDA records 9 decisions for Exigent Diagnostics, Inc. (Culver City, CA) in 1998: 9 510(k) clearances. Most are in product codes CEK (Biuret (Colorimetric), Total Protein) and JJF (Analyzer, Chemistry, Micro, For Clinical Use). Its devices cite 9 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 Exigent Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Exigent Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Exigent Diagnostics, Inc.

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?