510(k) K812593

ULTRA ZYME PLUS CK-1 #64978, 65027 & 28 by Harleco — Product Code CGS

K812593 is an FDA 510(k) premarket notification submitted by Harleco for the device "ULTRA ZYME PLUS CK-1 #64978, 65027 & 28". The FDA issued a decision of Substantially Equivalent on October 2, 1981. The device falls under product code CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Harleco has at least 10 other 510(k) clearances on record.