TITAN GEL CPK ISOENZYME SYSTEM

TITAN GEL CPK ISOENZYME SYSTEM is an FDA 510(k)-cleared medical device (K822124) manufactured by Helena Laboratories. 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 October 31, 1982. Regulation: 8.