510(k) K041074

BD FACSCANTO WITH BD FACSANTO SOFTWARE by Bd Biosciences — Product Code GKZ

K041074 is an FDA 510(k) premarket notification submitted by Bd Biosciences for the device "BD FACSCANTO WITH BD FACSANTO SOFTWARE". The FDA issued a decision of Substantially Equivalent on September 17, 2004. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Bd Biosciences has at least 9 other 510(k) clearances on record.