510(k) K911771

ARD(TM) ANTIMICROBIAL REMOVAL DEVICE by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LJK

K911771 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "ARD(TM) ANTIMICROBIAL REMOVAL DEVICE". The FDA issued a decision of Substantially Equivalent on July 1, 1991. The device falls under product code LJK (Antisera, If, 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.