MONOCLONAL MOUSE ANTI-HUMAN B-CELL

MONOCLONAL MOUSE ANTI-HUMAN B-CELL is an FDA 510(k)-cleared medical device (K943284) manufactured by Dako 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 November 20, 1994. Regulation: 8.