DYNAZYME-II TM LDH-L 340 KIT

DYNAZYME-II TM LDH-L 340 KIT is an FDA 510(k)-cleared medical device (K761343) manufactured by J.T. Baker Chemical Co.. 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 January 4, 1977. Regulation: 8.