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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 K073589
Device Name BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS
Applicant
Becton, Dickinson & CO
7 Loveton Cir.
Sparks,  MD  21152 -0999
Applicant Contact Monica Giguere
Correspondent
Becton, Dickinson & CO
7 Loveton Cir.
Sparks,  MD  21152 -0999
Correspondent Contact Monica Giguere
Regulation Number866.1645
Classification Product Code
LON  
Date Received12/20/2007
Decision Date 03/05/2008
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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