THROMBO-SCREEN AT-111 KIT

THROMBO-SCREEN AT-111 KIT is an FDA 510(k)-cleared medical device (K770394) manufactured by Bay Area Hema. Onco. Clinic. & Res. L. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 29, 1977. Regulation: 8.