THROMBIN-PREST REAGENT KIT

THROMBIN-PREST REAGENT KIT is an FDA 510(k)-cleared medical device (K884384) 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 December 27, 1988. Regulation: 8.