GlutenID Celiac Genetic Health Risk Test— 510(k) K241456

Name: FDA 510(k) clearance K241456
Creator: U.S. Food and Drug Administration
Published: 2025-01-07

Substantially Equivalent

Targeted Genomics, LLC

FDA 510(k) clearance K241456 for GlutenID Celiac Genetic Health Risk Test, Substantially Equivalent on 2025-01-07. Applicant: Targeted Genomics, LLC. Device class: 2.

Clearance details

Applicant: Targeted Genomics, LLC
Product code: Code PTA
Device class: Class 2
Regulation: 21 CFR 866.5950
Advisory panel: Immunology
Date received: 2024-05-22
Decision date: 2025-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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