510(k) K974578

GREPAFLOXACIN, 5 MG, SENSI-DISC by Becton Dickinson Microbiology Systems — Product Code JTN

K974578 is an FDA 510(k) premarket notification submitted by Becton Dickinson Microbiology Systems for the device "GREPAFLOXACIN, 5 MG, SENSI-DISC". The FDA issued a decision of Substantially Equivalent on February 23, 1998. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Becton Dickinson Microbiology Systems has at least 10 other 510(k) clearances on record.