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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 K023301
Device Name BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
Applicant
BECTON DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152
Applicant Contact MONICA E GIGUERE
Correspondent
BECTON DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152
Correspondent Contact MONICA E GIGUERE
Regulation Number866.1645
Classification Product Code
LON  
Date Received10/03/2002
Decision Date 11/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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