FDA 510(k) Application Details - K112545

Device Classification Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)   More FDA Info for this Device
510(K) Number	K112545
Device Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Applicant	INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. SAN DIEGO, CA 92131-1638 US Other 510(k) Applications for this Company
Contact	MICHAEL MAHLER 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	09/01/2011
Decision Date	07/31/2012
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