CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL

CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL is an FDA 510(k)-cleared medical device (K944247) 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 October 30, 1994. Regulation: 8.