PATHFAST CK-MB-II CALIBRATORS

PATHFAST CK-MB-II CALIBRATORS is an FDA 510(k)-cleared medical device (K130628) manufactured by Mitsubishi Chemical Medience Corporation. 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 October 3, 2013. Regulation: 8.