TITAN GEL LDH ISO-ENZYME CONTROL

TITAN GEL LDH ISO-ENZYME CONTROL is an FDA 510(k)-cleared medical device (K830872) 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 April 11, 1983. Regulation: 8.