Documento fuente o registro público

FDA 510(k) K250344 — BD Phoenix™ Automated Microbiology System

FDA 510(k) index record K250344. Device: BD Phoenix™ Automated Microbiology System. Applicant as listed: Becton, Dickinson and Company. Decision date: 2025-03-06.

OtherU.S. Food and Drug Administration (FDA)2025-03-06

Fuente

"device_name": "BD Phoenix™ Automated Microbiology System"

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-25

Disclaimer

professional use

FDA 510(k) public index record K250344.

Device name: BD Phoenix™ Automated Microbiology System. Applicant as listed: Becton, Dickinson and Company.

Decision date: 2025-03-06. Decision wording: Substantially Equivalent.

Product code: LON. Regulation: 21 CFR 866.1645. 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.

Interested in these solutions?

Submit a sourcing request with the assays, volumes, and timeline of your own project.

Explorar más