CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3

CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3 is an FDA 510(k)-cleared medical device (K932658) manufactured by More Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 27, 1993. Regulation: 8.