510(k) Report

FDA applicant

Icn Micromedic Systems

Horsham, PA4 decisions1988–19890 recalls

FDA records 4 decisions for Icn Micromedic Systems (Horsham, PA) from 1988 to 1989: 4 510(k) clearances. Most are in product codes KLN (Radioimmunoassay, Cocaine Metabolite) and JJJ (Counter (Beta, Gamma) For Clinical 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 toxicology panel, where it files most

How often FDA has decided Icn Micromedic Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Icn Micromedic Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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