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Polymedco Cancer Diagnostics, LLC
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OC-SENSOR DIANA IFOB TEST is an FDA 510(k)-cleared medical device (K092330) manufactured by Polymedco Cancer Diagnostics, LLC. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 7, 2010. Regulation: 8.