FDA applicant

Iso-Tex Diagnostics

Walker, MI3 decisions1979–19850 recalls

FDA records 3 decisions for Iso-Tex Diagnostics (Walker, MI) from 1979 to 1985: 3 510(k) clearances. Most are in product codes CEW (Radioimmunoassay, Parathyroid Hormone) and MSJ (Apolipoproteins). 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 Iso-Tex Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Iso-Tex Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Iso-Tex Diagnostics

Which product codes does it file in?

What has FDA decided for it lately?