HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT

HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT is an FDA 510(k)-cleared medical device (K924637) manufactured by International Technidyne Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 26, 1993. Regulation: 8.