EASYTOUCH TROMBOPLASTIN REAGENT

EASYTOUCH TROMBOPLASTIN REAGENT is an FDA 510(k)-cleared medical device (K832427) manufactured by Worthington Diagnostic Systems. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 13, 1983. Regulation: 8.