Source document or public record
FDA 510(k) K242706 — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
FDA 510(k) index record K242706. Device: Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. Applicant as listed: Fujirebio Diagnostics,Inc.. Decision date: 2025-05-16.
Source
"device_name": "Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio"
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
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FDA 510(k) public index record K242706.
Device name: Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. Applicant as listed: Fujirebio Diagnostics,Inc..
Decision date: 2025-05-16. Decision wording: Substantially Equivalent.
Product code: SET. Regulation: 21 CFR 866.5840. Medical specialty: Immunology.
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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