FDA 510(k) Application Details - K172252

Device Classification Name	Anti-Dna Indirect Immunofluorescent Solid Phase   More FDA Info for this Device
510(K) Number	K172252
Device Name	Anti-Dna Indirect Immunofluorescent Solid Phase
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	866.5100   More FDA Info for this Regulation Number
Classification Product Code	KTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2017
Decision Date	04/20/2018
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