CREATINE PHOSPHOKINASE (CPK) REAGENT SET

CREATINE PHOSPHOKINASE (CPK) REAGENT SET is an FDA 510(k)-cleared medical device (K792533) manufactured by Macomb Chemical Co.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 10, 1980. Regulation: 8.