Source document or public record
FDA 510(k) K250218 — Xpert® FII & FV
FDA 510(k) index record K250218. Device: Xpert® FII & FV. Applicant as listed: Cepheid. Decision date: 2025-02-21.
Source
"device_name": "Xpert® FII & FV"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K250218.
Device name: Xpert® FII & FV. Applicant as listed: Cepheid.
Decision date: 2025-02-21. Decision wording: Substantially Equivalent.
Product code: NPR. Regulation: 21 CFR 864.7280. Medical specialty: Hematology.
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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