ACS CKMB II IMMUNOASSAY

ACS CKMB II IMMUNOASSAY is an FDA 510(k)-cleared medical device (K962126) manufactured by Ciba Corning Diagnostics Corp.. 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 June 20, 1996. Regulation: 8.