• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name susceptibility test discs, antimicrobial
510(k) Number K112586
Device Name CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)
Original Applicant
BECTON DICKINSON AND COMPANY (BD)
7 loveton circle
mc 614
sparks,  MD  21152
Original Contact katie coyle
Regulation Number866.1620
Classification Product Code
JTN  
Date Received09/06/2011
Decision Date 10/18/2011
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-