Source document or public record
FDA 510(k) K221420 — AlphaID At Home Genetic Health Risk Service
FDA 510(k) index record K221420. Device: AlphaID At Home Genetic Health Risk Service. Applicant as listed: Progenika Biopharma S.A., A Grifols Company. Decision date: 2022-10-27.
Source
"device_name": "AlphaID At Home Genetic Health Risk Service"
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 K221420.
Device name: AlphaID At Home Genetic Health Risk Service. Applicant as listed: Progenika Biopharma S.A., A Grifols Company.
Decision date: 2022-10-27. Decision wording: Substantially Equivalent.
Product code: PTA. Regulation: 21 CFR 866.5950. 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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