Source document or public record
FDA 510(k) K253539 — Alere NT-proBNP for Alinity i
FDA 510(k) index record K253539. Device: Alere NT-proBNP for Alinity i. Applicant as listed: Axis-Shield Diagnostics, Ltd.. Decision date: 2026-02-18.
Source
"device_name": "Alere NT-proBNP for Alinity i"
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 K253539.
Device name: Alere NT-proBNP for Alinity i. Applicant as listed: Axis-Shield Diagnostics, Ltd..
Decision date: 2026-02-18. Decision wording: Substantially Equivalent.
Product code: NBC. Regulation: 21 CFR 862.1117. Medical specialty: Clinical Chemistry.
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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