HICHEM LDH/L REAGENT KIT

HICHEM LDH/L REAGENT KIT is an FDA 510(k)-cleared medical device (K946022) manufactured by Hichem Diagnostics. 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 February 22, 1995. Regulation: 8.