ACS ULTRA-1 THROMBOPLASTIN

ACS ULTRA-1 THROMBOPLASTIN is an FDA 510(k)-cleared medical device (K913249) manufactured by Analytical Control Systems, Inc.. 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, 1991. Regulation: 8.