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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 K051692
Device Name BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/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 Received06/23/2005
Decision Date 07/14/2005
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
Predetermined Change
Control Plan Authorized		 No
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