ASSAY KIT, THROMBO-SCREEN

ASSAY KIT, THROMBO-SCREEN is an FDA 510(k)-cleared medical device (K781880) 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 December 3, 1978. Regulation: 8.