510(k) K092868

CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 by CellaVision AB — Product Code JOY

K092868 is an FDA 510(k) premarket notification submitted by CellaVision AB for the device "CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127". The FDA issued a decision of Substantially Equivalent on November 20, 2009. The device falls under product code JOY (Device, Automated Cell-Locating), a Class II device regulated under 21 CFR 864.5260. CellaVision AB has at least 6 other 510(k) clearances on record.