510(k) K221826

BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) by Becton, Dickinson and Company — Product Code JTN

K221826 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)". The FDA issued a decision of Substantially Equivalent on December 21, 2022. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Becton, Dickinson and Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2022
Date Received
June 23, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Discs, Antimicrobial
Device Class
Class II
Regulation Number
866.1620
Review Panel
MI
Submission Type