COACUTE ANTITHROMBIN CHROMOGENIC ASSAY

COACUTE ANTITHROMBIN CHROMOGENIC ASSAY is an FDA 510(k)-cleared medical device (K902393) manufactured by Kabi Diagnostica. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 24, 1990. Regulation: 8.