FDA 510(k) Application Details - K193115

Device Classification Name	Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230   More FDA Info for this Device
510(K) Number	K193115
Device Name	Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
Applicant	Euroimmun US, Inc. 1 Bloomfield Ave. Mountain Lakes, NJ 07046 US Other 510(k) Applications for this Company
Contact	Kruti Shah Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	OEG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2019
Decision Date	09/17/2020
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