510(k) K062087

BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 by Bd Biosciences — Product Code GKZ

K062087 is an FDA 510(k) premarket notification submitted by Bd Biosciences for the device "BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962". The FDA issued a decision of Substantially Equivalent on September 14, 2006. 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.