SIGMA PROCEDURE #550 DETERM. BILIRUB

SIGMA PROCEDURE #550 DETERM. BILIRUB is an FDA 510(k)-cleared medical device (K832236) manufactured by Sigma Chemical 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 August 30, 1983. Regulation: 8.