FDA 510(k) Application Details - K200230

Device Classification Name	Autoantibodies, Endomysial(Tissue Transglutaminase)   More FDA Info for this Device
510(K) Number	K200230
Device Name	Autoantibodies, Endomysial(Tissue Transglutaminase)
Applicant	Inova Diagnostics, Inc. 9900 Old Grove Rd. 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	01/30/2020
Decision Date	08/26/2021
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