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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 K250344
Device Name BD Phoenix™ Automated Microbiology System
Applicant
Becton, Dickinson and Company
7 Loveton Circle
Sparks,  MD  21152
Applicant Contact Katherine Cicala
Correspondent
Becton, Dickinson and Company
7 Loveton Circle
Sparks,  MD  21152
Correspondent Contact Katherine Cicala
Regulation Number866.1645
Classification Product Code
LON  
Date Received02/06/2025
Decision Date 03/06/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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