510(k) K851639

ANTI-LEU-12 B CELL REAGENT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LJD

K851639 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "ANTI-LEU-12 B CELL REAGENT". The FDA issued a decision of Substantially Equivalent on July 2, 1986. The device falls under product code LJD (Assay, B Lymphocyte Marker), a Class II device regulated under 21 CFR 864.5220. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.