510(k) K842218

ANTI-LEU-4 FITC LYSIN C BUFFER by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LIZ

K842218 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "ANTI-LEU-4 FITC LYSIN C BUFFER". The FDA issued a decision of Substantially Equivalent on December 27, 1984. The device falls under product code LIZ (Assay, T Lymphocyte Surface 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.