Source document or public record
FDA 510(k) K241456 — GlutenID Celiac Genetic Health Risk Test
FDA 510(k) index record K241456. Device: GlutenID Celiac Genetic Health Risk Test. Applicant as listed: Targeted Genomics, LLC. Decision date: 2025-01-07.
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"device_name": "GlutenID Celiac Genetic Health Risk Test"
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 K241456.
Device name: GlutenID Celiac Genetic Health Risk Test. Applicant as listed: Targeted Genomics, LLC.
Decision date: 2025-01-07. 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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