FDA 510(k) Application Details - K092601

Device Classification Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)   More FDA Info for this Device
510(K) Number	K092601
Device Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Applicant	IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. BUFFALO, NY 14228-2120 US Other 510(k) Applications for this Company
Contact	KEVIN LAWSON 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	08/24/2009
Decision Date	10/07/2010
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