510(k) K090967

BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 by Bd Biosciences — Product Code GKZ

K090967 is an FDA 510(k) premarket notification submitted by Bd Biosciences for the device "BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611". The FDA issued a decision of Substantially Equivalent on July 31, 2009. 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.