510(k) K182702

SEKURE Creatine Kinase Assay by Sekisui Diagnostics P.E.I., Inc. — Product Code CGS

K182702 is an FDA 510(k) premarket notification submitted by Sekisui Diagnostics P.E.I., Inc. for the device "SEKURE Creatine Kinase Assay". The FDA issued a decision of Substantially Equivalent on April 17, 2019. The device falls under product code CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Sekisui Diagnostics P.E.I., Inc. has at least 5 other 510(k) clearances on record.