B-FACT, BORDERLINE FACTOR ASSAY CONTROL

B-FACT, BORDERLINE FACTOR ASSAY CONTROL is an FDA 510(k)-cleared medical device (K945854) manufactured by George King Bio-Medical, 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 October 23, 1995. Regulation: 8.