COULTER CLONE B4 MONOCLONAL ANTIBODY

COULTER CLONE B4 MONOCLONAL ANTIBODY is an FDA 510(k)-cleared medical device (K884020) manufactured by Coulter Immunology. 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 2, 1989. Regulation: 8.