BECKMAN DIRECT BILIRUBIN REAGENT

BECKMAN DIRECT BILIRUBIN REAGENT is an FDA 510(k)-cleared medical device (K934068) manufactured by Beckman-Diagnostic Systems Group. 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 25, 1994. Regulation: 8.