FDA 510(k) Application Details - K083850

Device Classification Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)   More FDA Info for this Device
510(K) Number	K083850
Device Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Applicant	EUROIMMUN US INC 95 WASHINGTON ST MORRISTOWN, NJ 07960 US Other 510(k) Applications for this Company
Contact	KATHRYN KOHL 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	12/24/2008
Decision Date	05/20/2009
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