LANCER MB/CPK ISOENZYME KIT

LANCER MB/CPK ISOENZYME KIT is an FDA 510(k)-cleared medical device (K760871) manufactured by Sherwood Medical Industries. 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 November 1, 1976. Regulation: 8.