Source document or public record

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

FDA 510(k) index record K221826. Device: BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30). Applicant as listed: Becton, Dickinson and Company. Decision date: 2022-12-21.

OtherU.S. Food and Drug Administration (FDA)2022-12-21

Source

"device_name": "BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)"

This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-20

Disclaimer

professional use

FDA 510(k) public index record K221826.

Device name: BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30). Applicant as listed: Becton, Dickinson and Company.

Decision date: 2022-12-21. Decision wording: Substantially Equivalent.

Product code: JTN. Regulation: 21 CFR 866.1620. Medical specialty: Microbiology.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

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