Source document or public record
FDA 510(k) K221817 — ALFIS Vitamin D, ALFIS-3 Analyzer
FDA 510(k) index record K221817. Device: ALFIS Vitamin D, ALFIS-3 Analyzer. Applicant as listed: Immunostics Inc.,. Decision date: 2023-09-22.
Source
"device_name": "ALFIS Vitamin D, ALFIS-3 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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2026-10-20
2026-10-20
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FDA 510(k) public index record K221817.
Device name: ALFIS Vitamin D, ALFIS-3 Analyzer. Applicant as listed: Immunostics Inc.,.
Decision date: 2023-09-22. Decision wording: Substantially Equivalent.
Product code: MRG. Regulation: 21 CFR 862.1825. 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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