I-STAT CREATINE KINASE MB (CK-MB)

I-STAT CREATINE KINASE MB (CK-MB) is an FDA 510(k)-cleared medical device (K051433) manufactured by I-Stat 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 December 14, 2005. Regulation: 8.