FDA 510(k) Application Details - K183313

Device Classification Name	Autoantibodies, Endomysial(Tissue Transglutaminase)   More FDA Info for this Device
510(K) Number	K183313
Device Name	Autoantibodies, Endomysial(Tissue Transglutaminase)
Applicant	Euroimmun US, Inc. 1 Bloomfield Avenue Mountain Lakes, NJ 07046 US Other 510(k) Applications for this Company
Contact	Daniel Castellanos 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	11/29/2018
Decision Date	02/28/2019
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