CARDIOZYME CK CONTROL NORMAL

CARDIOZYME CK CONTROL NORMAL is an FDA 510(k)-cleared medical device (K770973) manufactured by Dade, Baxter Travenol Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 3, 1977. Regulation: 8.