FDA applicant

Clinical Assays, Inc.

Mchenry, IL27 decisions1977–19830 recalls

FDA records 27 decisions for Clinical Assays, Inc. (Mchenry, IL) from 1977 to 1983: 27 510(k) clearances. Most are in product codes CGN (Acid, Folic, Radioimmunoassay) and CDX (Radioimmunoassay, Total Thyroxine). 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 Clinical Assays, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Clinical Assays, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Clinical Assays, Inc.

Which product codes does it file in?

What has FDA decided for it lately?