OLYMPUS CREATINE KINASE REAGENT OSR6179/6279

OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 is an FDA 510(k)-cleared medical device (K994189) manufactured by Olympus Diagnostica GmbH. 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 19, 2000. Regulation: 8.