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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Genetic Variant Detection And Health Risk Assessment System
510(k) Number K241456
Device Name GlutenID Celiac Genetic Health Risk Test
Applicant
Targeted Genomics, LLC
5 Mason
Irvine,  CA  92618
Applicant Contact Shelly Gunn
Correspondent
Medical Device Academy, Inc.
345
Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Bhoomika Joyappa
Regulation Number866.5950
Classification Product Code
PTA  
Date Received05/22/2024
Decision Date 01/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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