Documento fuente o registro público
FDA 510(k) K260213 — BD BACTEC FXI Culture System
FDA 510(k) index record K260213. Device: BD BACTEC FXI Culture System. Applicant as listed: BD Diagnostic Systems. Decision date: 2026-05-28.
Fuente
"device_name": "BD BACTEC FXI Culture 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
Automated FDA record verification
2026-10-20
2026-10-22
professional use
FDA 510(k) public index record K260213.
Device name: BD BACTEC FXI Culture System. Applicant as listed: BD Diagnostic Systems.
Decision date: 2026-05-28. Decision wording: Substantially Equivalent.
Product code: MDB. Regulation: 21 CFR 866.2560. 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.