510(k) K160570

Creatine Kinase by Roche Diagnostics Operations (Rdo) — Product Code JHS

K160570 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Operations (Rdo) for the device "Creatine Kinase". The FDA issued a decision of Substantially Equivalent on May 25, 2016. The device falls under product code JHS (Differential Rate Kinetic Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Roche Diagnostics Operations (Rdo) has at least 10 other 510(k) clearances on record.