BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML


Device Classification Name

system, test, automated, antimicrobial susceptibility, short incubation

510(k) Number K050745
Device Name BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML
Applicant
BECTON, DICKINSON & CO.
7 loveton cir.
sparks, 
MD 
21152 -0999

Applicant Contact monica e giguere
Correspondent
BECTON, DICKINSON & CO.
7 loveton cir.
sparks, 
MD 
21152 -0999

Correspodent Contact monica e giguere
Regulation Number 866.1645
Classification Product Code
LON  
Date Received 03/22/2005
Decision Date 04/29/2005
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