# Icn Biomedicals, Inc.

- Location (FDA's records): Costa Mesa, CA
- FDA decisions: 11 (1988–2003): 11 510(k) clearances
- Product codes: JLW (2), JHI (1), DJR (1), CGJ (1), CEP (1), DKX (1), JNB (1), JLX (1), CFT (1), JCF (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K030211: Rapid Barbiturate Test Strip and Test Card, Models 7015 and 7016 (Jun 13, 2003)
- K023252: Rapid Methadone Test Strip, Model 7019 & Rapid Methadone Test Card, Model 7020 (Nov 22, 2002)
- K926106: Immuchem Phe-MW EA (Feb 8, 1995)
- K922944: Immuchem LH-MW Elisa (Feb 2, 1993)
- K922376: Icn Biomedicals Immuchem (TM) FSH-MW Elisa Kit (Oct 5, 1992)
- K922715: Immuchem PRL-MW Elisa (Oct 5, 1992)
- K920442: Immuchem TSH-MW Elisa (Mar 18, 1992)
- K913963: Immuchem Neonatal TSH-MP Elisa (Dec 13, 1991)

Source page: https://510kreport.com/company/icn-biomedicals