AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD)

AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD) is an FDA 510(k)-cleared medical device (K900571) manufactured by American Research Products 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 April 15, 1990. Regulation: 8.