Source document or public record
FDA 510(k) K214117 — Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer
FDA 510(k) index record K214117. Device: Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer. Applicant as listed: Abbott Diagnostics Technologies AS. Decision date: 2023-09-27.
Source
"device_name": "Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer"
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 K214117.
Device name: Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer. Applicant as listed: Abbott Diagnostics Technologies AS.
Decision date: 2023-09-27. Decision wording: Substantially Equivalent.
Product code: LCP. Regulation: 21 CFR 864.7470. 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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