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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Susceptibility Test Discs, Antimicrobial
510(k) Number K221826
Device Name BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)
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 Number866.1620
Classification Product Code
JTN  
Date Received06/23/2022
Decision Date 12/21/2022
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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