
Jas Diagnostics, Inc.
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CREATINE KINASE (CK-NAC) is an FDA 510(k)-cleared medical device (K013912) manufactured by Jas Diagnostics, Inc.. 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 January 17, 2002. Regulation: 8.