CKMB CONTROL - LEVEL 1,2,3

CKMB CONTROL - LEVEL 1,2,3 is an FDA 510(k)-cleared medical device (K930875) manufactured by Cala Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 12, 1993. Regulation: 8.