CARDIO REP CK ISOENZYME KIT - 3310

CARDIO REP CK ISOENZYME KIT - 3310 is an FDA 510(k)-cleared medical device (K931050) manufactured by Helena Laboratories. 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 April 19, 1993. Regulation: 8.