BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM – NORFLOXACIN 0.25 – 16 UG/ML


Device Classification Name

system, test, automated, antimicrobial susceptibility, short incubation

510(k) Number K030091
Device Name BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM – NORFLOXACIN 0.25 – 16 UG/ML
Original Applicant
BD DIAGNOSTIC SYSTEMS
7 loveton circle
sparks, 
MD 
21152

Original Contact kathryn babka powers
Regulation Number 866.1645
Classification Product Code
LON  
Date Received 01/10/2003
Decision Date 02/28/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No