LAS-R HUMAN ANTITHROMBIN III TEST

LAS-R HUMAN ANTITHROMBIN III TEST is an FDA 510(k)-cleared medical device (K772328) manufactured by Hyland Therapeutic Div., Travenol Laboratories. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 2, 1978. Regulation: 8.