510(k) K881102

MICROMEDIC MORPHINE RIA KIT by Icn Micromedic Systems — Product Code DOE

K881102 is an FDA 510(k) premarket notification submitted by Icn Micromedic Systems for the device "MICROMEDIC MORPHINE RIA KIT". The FDA issued a decision of Substantially Equivalent on June 24, 1988. The device falls under product code DOE (Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.), a Class II device regulated under 21 CFR 862.3640. Icn Micromedic Systems has at least 3 other 510(k) clearances on record.