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Ventana Medical Sytems, Inc.
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CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY is an FDA 510(k)-cleared medical device (K103818) manufactured by Ventana Medical Sytems, Inc.. 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 15, 2011. Regulation: 8.