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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
7 Loveton Circle
Sparks,  MD  21152 -0999
Applicant Contact Kamisha Gray
Correspondent
Becton Dickinson, and Company
7 Loveton Circle
Sparks,  MD  21152 -0999
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
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