510(k) K821883

ULTRAZYME PLUS CK-I by Harleco Diagnostics — Product Code CGS

K821883 is an FDA 510(k) premarket notification submitted by Harleco Diagnostics for the device "ULTRAZYME PLUS CK-I". The FDA issued a decision of Substantially Equivalent on July 14, 1982. 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 Diagnostics has at least 10 other 510(k) clearances on record.