THROMBO-CALIBRATOR KIT

THROMBO-CALIBRATOR KIT is an FDA 510(k)-cleared medical device (K921344) manufactured by American Bioproducts Co.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 8, 1992. Regulation: 8.