DADE PROTEIN C CLOTTING ASSAY

DADE PROTEIN C CLOTTING ASSAY is an FDA 510(k)-cleared medical device (K903468) manufactured by Baxter Healthcare Corp. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 25, 1991. Regulation: 8.