FDA 510(k) Application Details - K193604

Device Classification Name	Autoantibodies, Endomysial(Tissue Transglutaminase)   More FDA Info for this Device
510(K) Number	K193604
Device Name	Autoantibodies, Endomysial(Tissue Transglutaminase)
Applicant	Inova Diagnostics, Inc. 9900 Old Grove Road San Diego, CA 92131-1638 US Other 510(k) Applications for this Company
Contact	Andrea Seaman Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	MVM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2019
Decision Date	06/16/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review