510(k) K850768

TOXOSCAN CARD TEST KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LLA

K850768 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "TOXOSCAN CARD TEST KIT". The FDA issued a decision of Substantially Equivalent on May 20, 1985. 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.