DADE FACTOR VIII CHROMOGENIC ASSAY

DADE FACTOR VIII CHROMOGENIC ASSAY is an FDA 510(k)-cleared medical device (K884544) 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 December 29, 1988. Regulation: 8.