TITAN GEL REP CPK/LDH ISOENZYME CONTROL

TITAN GEL REP CPK/LDH ISOENZYME CONTROL is an FDA 510(k)-cleared medical device (K874141) 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 November 3, 1987. Regulation: 8.