510(k) K003062

BACTEC MGIT 960 SIR KITS by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code MJA

K003062 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "BACTEC MGIT 960 SIR KITS". The FDA issued a decision of Substantially Equivalent on June 6, 2001. The device falls under product code MJA (Susceptibility Test Powders, Antimycobacterial), a Class II device regulated under 21 CFR 866.1640. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.