TITAN GEL CPK/LDH ISOENZYME CONTROL

TITAN GEL CPK/LDH ISOENZYME CONTROL is an FDA 510(k)-cleared medical device (K821981) manufactured by Helena Laboratories. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 21, 1982. Regulation: 8.