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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Susceptibility Test Discs, Antimicrobial
510(k) Number K112586
Device Name CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)
Applicant
BECTON DICKINSON AND COMPANY (BD)
7 LOVETON CIRCLE
MC 614
SPARKS,  MD  21152
Applicant Contact KATIE COYLE
Correspondent
BECTON DICKINSON AND COMPANY (BD)
7 LOVETON CIRCLE
MC 614
SPARKS,  MD  21152
Correspondent Contact KATIE COYLE
Regulation Number866.1620
Classification Product Code
JTN  
Date Received09/06/2011
Decision Date 10/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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