BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)— 510(k) K221826

Substantially Equivalent

Becton, Dickinson and Company

FDA 510(k) clearance K221826 for BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30), Substantially Equivalent on 2022-12-21. Applicant: Becton, Dickinson and Company. Device class: 2.

Clearance details

Applicant
Becton, Dickinson and Company
Product code
Code JTN
Device class
Class 2
Regulation
21 CFR 866.1620
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sparks, MD, US
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