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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 K062945
Device Name BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML
Applicant
BECTON, DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152 -0999
Applicant Contact VICKI L KENNEDY
Correspondent
BECTON, DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152 -0999
Correspondent Contact VICKI L KENNEDY
Regulation Number866.1645
Classification Product Code
LON  
Date Received09/28/2006
Decision Date 11/21/2006
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
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