DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR

DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR is an FDA 510(k)-cleared medical device (K993957) 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 March 2, 2000. Regulation: 8.