
Lab Vision Corp.
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NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2) is an FDA 510(k)-cleared medical device (K060462) 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 April 23, 2006. Regulation: 8.