SIGMA PROCEDURE NO. 745 - EP.REAGENT SY

SIGMA PROCEDURE NO. 745 - EP.REAGENT SY is an FDA 510(k)-cleared medical device (K760591) 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 October 28, 1976. Regulation: 8.