510(k) K895362

BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JTT

K895362 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST". The FDA issued a decision of Substantially Equivalent on December 1, 1989. The device falls under product code JTT (Susceptibility Test Powders, Antimicrobial), 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.