FDA 510(k) Application Details - K161258

Device Classification Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)   More FDA Info for this Device
510(K) Number	K161258
Device Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Applicant	INOVA DIAGNOSTICS, INC. 9900 OLD GROVE ROAD SAN DIEGO, CA 92131 US Other 510(k) Applications for this Company
Contact	Gabriella Lakos Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	MOB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/2016
Decision Date	02/03/2017
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