510(k) K811576

CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A) by Harleco — Product Code CGS

K811576 is an FDA 510(k) premarket notification submitted by Harleco for the device "CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)". The FDA issued a decision of Substantially Equivalent on June 25, 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.