HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS

HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS is an FDA 510(k)-cleared medical device (K923593) 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 September 21, 1992. Regulation: 8.