510(k) K060375

BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 by Bd Biosciences — Product Code GKZ

K060375 is an FDA 510(k) premarket notification submitted by Bd Biosciences for the device "BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166". The FDA issued a decision of Substantially Equivalent on June 6, 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.