PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY

PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY is an FDA 510(k)-cleared medical device (K770942) manufactured by Pharmaseal Div., 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 July 20, 1977. Regulation: 8.