ANTITHROMBIN III ASSAY

ANTITHROMBIN III ASSAY is an FDA 510(k)-cleared medical device (K781480) manufactured by Dade, Baxter Travenol Diagnostics, 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 November 7, 1978. Regulation: 8.