CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)


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

Correspodent Contact katie coyle
Regulation Number 866.1620
Classification Product Code
JTN  
Date Received 09/06/2011
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