510(k) K080595

CELLAVISION DM96 WITH THE BODY FLUID APPLICATION by CellaVision AB — Product Code JOY

K080595 is an FDA 510(k) premarket notification submitted by CellaVision AB for the device "CELLAVISION DM96 WITH THE BODY FLUID APPLICATION". The FDA issued a decision of Substantially Equivalent on December 5, 2008. 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.