510(k) K081213

BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 by Bd Biosciences — Product Code GKZ

K081213 is an FDA 510(k) premarket notification submitted by Bd Biosciences for the device "BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010". The FDA issued a decision of Substantially Equivalent on August 14, 2008. 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.