HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806

HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 is an FDA 510(k)-cleared medical device (K925550) 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 April 19, 1993. Regulation: 8.