
Dako North America, Inc.
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MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI is an FDA 510(k)-cleared medical device (K120663) manufactured by Dako North America, 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 February 11, 2013. Regulation: 8.