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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 K251713
Device Name BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
Applicant
Becton, Dickinson and Company
7loveton Cir.
Sparks,  MD  21152
Applicant Contact Kamisha Gray
Correspondent
Becton, Dickinson and Company
7loveton Cir.
Sparks,  MD  21152
Correspondent Contact Kamisha Gray
Regulation Number866.1645
Classification Product Code
LON  
Date Received06/03/2025
Decision Date 08/08/2025
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		 Yes
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