Source document or public record
FDA 510(k) K231348 — Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF
FDA 510(k) index record K231348. Device: Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF. Applicant as listed: Roche Diagnostics. Decision date: 2023-06-05.
Source
"device_name": "Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF"
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 K231348.
Device name: Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF. Applicant as listed: Roche Diagnostics.
Decision date: 2023-06-05. Decision wording: Substantially Equivalent.
Product code: QSE. 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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