HICHEM CALCIUM REAGENT KIT

HICHEM CALCIUM REAGENT KIT is an FDA 510(k)-cleared medical device (K981794) 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 July 28, 1998. Regulation: 8.