Source document or public record
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.
Source
"device_name": "BD BACTEC FXI Culture System"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
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.
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