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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 K023858
Device Name BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
Applicant
BECTON, DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152 -0999
Applicant Contact KATHRYN BABKA POWERS
Correspondent
BECTON, DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152 -0999
Correspondent Contact KATHRYN BABKA POWERS
Regulation Number866.1645
Classification Product Code
LON  
Date Received11/20/2002
Decision Date 12/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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