ACS FREEZE-DRIED APTT REAGENT

ACS FREEZE-DRIED APTT REAGENT is an FDA 510(k)-cleared medical device (K921223) 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 17, 1992. Regulation: 8.