510(k) K071141

BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 by Bd Biosciences — Product Code GKZ

K071141 is an FDA 510(k) premarket notification submitted by Bd Biosciences for the device "BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402". The FDA issued a decision of Substantially Equivalent on June 6, 2007. 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.