BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML


Device Classification Name

system, test, automated, antimicrobial susceptibility, short incubation

510(k) Number K073433
Device Name BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML
Applicant
BECTON, DICKINSON & CO.
7 loveton cir.
sparks, 
MD 
21152 -0999

Applicant Contact vicki k whitley
Correspondent
BECTON, DICKINSON & CO.
7 loveton cir.
sparks, 
MD 
21152 -0999

Correspodent Contact vicki k whitley
Regulation Number 866.1645
Classification Product Code
LON  
Date Received 12/06/2007
Decision Date 01/14/2008
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