510(k) K000829

GATIFLOXACIN, 5 UG, BBL SENSI-DISC by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JTN

K000829 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "GATIFLOXACIN, 5 UG, BBL SENSI-DISC". The FDA issued a decision of Substantially Equivalent on April 13, 2000. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.