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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 K033784
Device Name BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML
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 Received12/04/2003
Decision Date 02/03/2004
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
Recalls CDRH Recalls
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