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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 K023444
Device Name BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMIKACIN-0.5-64 UG/ML
Applicant
Becton, Dickinson & CO
7 Loveton Cir.
Sparks,  MD  21152 -0999
Applicant Contact BRADFORD SPRING
Correspondent
Becton, Dickinson & CO
7 Loveton Cir.
Sparks,  MD  21152 -0999
Correspondent Contact BRADFORD SPRING
Regulation Number866.1645
Classification Product Code
LON  
Date Received10/15/2002
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
Predetermined Change
Control Plan Authorized		 No
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