510(k) K821803

QBC CENTRIFUGAL HEMATOLOGY SYSTEM by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GKG

K821803 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "QBC CENTRIFUGAL HEMATOLOGY SYSTEM". The FDA issued a decision of Substantially Equivalent on September 14, 1982. The device falls under product code GKG (Centrifuge, Hematocrit), a Class II device regulated under 21 CFR 864.6400. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.