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Leica Biosystems Newcastle, Ltd.
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VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) is an FDA 510(k)-cleared medical device (K122556) manufactured by Leica Biosystems Newcastle, Ltd.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 18, 2014. Regulation: 8.