FDA applicant

Wien Laboratories, Inc.

Mchenry, IL13 decisions1977–19910 recalls

FDA records 13 decisions for Wien Laboratories, Inc. (Mchenry, IL) from 1977 to 1991: 13 510(k) clearances. Most are in product codes CDZ (Radioimmunoassay, Testosterones And…) and JKC (Radioimmunoassay, Dehydroepiandrosterone (Free…). 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 Wien Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wien Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Wien Laboratories, Inc.

Which product codes does it file in?

What has FDA decided for it lately?