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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 K123266
Device Name BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN
Applicant
Becton, Dickinson and Company
7 Loveton Circle, Mc 614
Sparks,  MD  21152
Applicant Contact MONICA E GIGUERE
Correspondent
Becton, Dickinson and Company
7 Loveton Circle, Mc 614
Sparks,  MD  21152
Correspondent Contact MONICA E GIGUERE
Regulation Number866.1645
Classification Product Code
LON  
Date Received10/19/2012
Decision Date 06/26/2013
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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