COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY

COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY is an FDA 510(k)-cleared medical device (K894179) 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 11, 1990. Regulation: 8.