510(k) K112586

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2011
Date Received
September 6, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Discs, Antimicrobial
Device Class
Class II
Regulation Number
866.1620
Review Panel
MI
Submission Type