Source document or public record
FDA 510(k) K243489 — Alinity m EBV (09N43-095)
FDA 510(k) index record K243489. Device: Alinity m EBV (09N43-095). Applicant as listed: Abbott Molecular, Inc.. Decision date: 2025-07-28.
Source
"device_name": "Alinity m EBV (09N43-095)"
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 K243489.
Device name: Alinity m EBV (09N43-095). Applicant as listed: Abbott Molecular, Inc..
Decision date: 2025-07-28. Decision wording: Substantially Equivalent.
Product code: QLX. Regulation: 21 CFR 866.3183. 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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