DYNAZYME TM II CARDIAK-MB

DYNAZYME TM II CARDIAK-MB is an FDA 510(k)-cleared medical device (K772172) manufactured by J.T. Baker 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 December 5, 1977. Regulation: 8.