FDA 510(k) Application Details - K241456

Device Classification Name	More FDA Info for this Device
510(K) Number	K241456
Device Name	GlutenID Celiac Genetic Health Risk Test
Applicant	Targeted Genomics, LLC 5 Mason Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Shelly Gunn Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PTA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2024
Decision Date	01/07/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review