510(k) K981218

CREATINE KINASE (CK) by Abbott Laboratories — Product Code CGS

K981218 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "CREATINE KINASE (CK)". The FDA issued a decision of Substantially Equivalent on May 1, 1998. The device falls under product code CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Abbott Laboratories has at least 10 other 510(k) clearances on record.