
Lab Vision Corp.
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NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1) is an FDA 510(k)-cleared medical device (K061360) manufactured by Lab Vision Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 26, 2006. Regulation: 8.