510(k) K112586

CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) by Becton, Dickinson and Company (BD) — Product Code JTN

K112586 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company (BD) for the device "CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)". The FDA issued a decision of Substantially Equivalent on October 18, 2011. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Becton, Dickinson and Company (BD) has at least 4 other 510(k) clearances on record.