DORIPENEM 10UG BBL SENSI-DISC


Device Classification Name

susceptibility test discs, antimicrobial

510(k) Number K080998
Device Name DORIPENEM 10UG BBL SENSI-DISC
Applicant
BECTON DICKINSON & CO.
7 loveton cir.
sparks, 
MD 
21152

Applicant Contact janine matlak
Correspondent
BECTON DICKINSON & CO.
7 loveton cir.
sparks, 
MD 
21152

Correspodent Contact janine matlak
Regulation Number 866.1620
Classification Product Code
JTN  
Date Received 04/07/2008
Decision Date 05/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No