BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR

BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR is an FDA 510(k)-cleared medical device (K012960) 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 March 7, 2002. Regulation: 8.