ACS ONE-STAGE PROTHROMBIN TIME REAGENT

ACS ONE-STAGE PROTHROMBIN TIME REAGENT is an FDA 510(k)-cleared medical device (K902468) manufactured by Analytical Control Systems, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 9, 1990. Regulation: 8.