CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127

CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 is an FDA 510(k)-cleared medical device (K092868) 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 November 19, 2009. Regulation: 8.