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CellaVision AB
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CELLAVISION DM96 WITH THE BODY FLUID APPLICATION is an FDA 510(k)-cleared medical device (K080595) manufactured by CellaVision AB. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 4, 2008. Regulation: 8.