FDA 510(k) Application Details - K163525

Device Classification Name	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control   More FDA Info for this Device
510(K) Number	K163525
Device Name	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant	Inova Diagnostics, Inc. 9900 Old Grove Road San Diego, CA 92131-1638 US Other 510(k) Applications for this Company
Contact	Peter Martis Other 510(k) Applications for this Contact
Regulation Number	866.5090   More FDA Info for this Regulation Number
Classification Product Code	DBM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2016
Decision Date	09/05/2017
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