
CellaVision AB
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DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER is an FDA 510(k)-cleared medical device (K003301) 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 March 14, 2001. Regulation: 8.