
Harleco
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CARDIOZYME PLUS CK-MB ITEM #65045 (G) is an FDA 510(k)-cleared medical device (K811575) manufactured by Harleco. 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 24, 1981. Regulation: 8.