BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS


Device Classification Name

system, test, automated, antimicrobial susceptibility, short incubation

510(k) Number K073589
Device Name BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS
Applicant
BECTON, DICKINSON & CO.
7 loveton cir.
sparks, 
MD 
21152 -0999

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

Correspodent Contact monica giguere
Regulation Number 866.1645
Classification Product Code
LON  
Date Received 12/20/2007
Decision Date 03/05/2008
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