510(k) K831930

TOXO-SCREEN DA TEST by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LLA

K831930 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "TOXO-SCREEN DA TEST". The FDA issued a decision of Substantially Equivalent on September 26, 1983. The device falls under product code LLA (Direct Agglutination Test, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.