510(k) K841520

CMV LATEX AGGLUTINATION TEST KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LJO

K841520 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "CMV LATEX AGGLUTINATION TEST KIT". The FDA issued a decision of Substantially Equivalent on September 7, 1984. The device falls under product code LJO (Antigen, Iha, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.