FDA applicant

Icn Biomedicals, Inc.

Costa Mesa, CA11 decisions1988–20030 recalls

FDA records 11 decisions for Icn Biomedicals, Inc. (Costa Mesa, CA) from 1988 to 2003: 11 510(k) clearances. Most are in product codes JLW (Radioimmunoassay, Thyroid-Stimulating Hormone) and JHI (Visual, Pregnancy Hcg, Prescription Use). 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 Icn Biomedicals, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Icn Biomedicals, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Icn Biomedicals, Inc.

Which product codes does it file in?

What has FDA decided for it lately?