BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)

BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) is an FDA 510(k)-cleared medical device (K013148) manufactured by Biogenex Laboratories. 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 27, 2002. Regulation: 8.