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FDA 510(k)

GlutenID Celiac Genetic Health Risk Test

K-Number: K241456 · 2025-01-07

ApplicantTargeted Genomics, LLC
Decision Date2025-01-07
Product CodePTA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GlutenID Celiac Genetic Health Risk Test is the device name listed in this FDA 510(k) record. The listed applicant is Targeted Genomics, LLC. It received FDA 510(k) clearance on 2025-01-07 under 510(k) number K241456. The device is classified under product code PTA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GlutenID Celiac Genetic Health Risk Test?

GlutenID Celiac Genetic Health Risk Test is a medical device that received FDA 510(k) clearance on 2025-01-07. The listed applicant is Targeted Genomics, LLC. The 510(k) number is K241456.

When did GlutenID Celiac Genetic Health Risk Test receive FDA 510(k) clearance?

GlutenID Celiac Genetic Health Risk Test received FDA 510(k) clearance on 2025-01-07, under 510(k) number K241456.

Who is the listed applicant for GlutenID Celiac Genetic Health Risk Test?

The FDA 510(k) record lists Targeted Genomics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GlutenID Celiac Genetic Health Risk Test?

The FDA product code for GlutenID Celiac Genetic Health Risk Test is PTA.

Related Devices (Code: PTA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221420AlphaID™ At Home Genetic Health Risk ServiceProgenika Biopharma S.A., A Grifols CompanyK192073Helix Genetic Health Risk App for late-onset Alzheimer’s diseaseHelix Opco, LLCK192944AncestryDNA Factor V Leiden Genetic Health Risk TestAncestry Genomics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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