510(k) K970385

SPARFLOZACIN, 5 MCG, SENSI-DISC by Becton Dickinson Microbiology Systems — Product Code JTN

K970385 is an FDA 510(k) premarket notification submitted by Becton Dickinson Microbiology Systems for the device "SPARFLOZACIN, 5 MCG, SENSI-DISC". The FDA issued a decision of Substantially Equivalent on March 10, 1997. 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.