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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, automated, antimicrobial susceptibility, short incubation
510(k) Number K051183
Device Name BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GATIFLOXACIN (STREP) 0.0625 -8UG/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
Correspondent Contact MONICA E GIGUERE
Regulation Number866.1645
Classification Product Code
LON  
Date Received05/09/2005
Decision Date 06/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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