FDA applicant
Icn Micromedic Systems
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
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.
Planning a device like Icn Micromedic Systems’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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