TITAN GEL ISO DOT LDH KIT

TITAN GEL ISO DOT LDH KIT is an FDA 510(k)-cleared medical device (K842669) 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 8, 1984. Regulation: 8.