TITAN GEL REP LDH-12 HV

TITAN GEL REP LDH-12 HV is an FDA 510(k)-cleared medical device (K874143) 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 November 22, 1987. Regulation: 8.