PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT

PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT is an FDA 510(k)-cleared medical device (K801460) manufactured by Pacific Hemostasis. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 27, 1980. Regulation: 8.