HICHEM ALP/AMP REAGENT KIT

HICHEM ALP/AMP REAGENT KIT is an FDA 510(k)-cleared medical device (K963383) 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 September 22, 1996. Regulation: 8.