510(k) K881005

IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG by Icn Biomedicals, Inc. — Product Code JHI

K881005 is an FDA 510(k) premarket notification submitted by Icn Biomedicals, Inc. for the device "IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG". The FDA issued a decision of Substantially Equivalent on May 27, 1988. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Icn Biomedicals, Inc. has at least 10 other 510(k) clearances on record.