FDA 510(k) Application Details - K040586

Device Classification Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)   More FDA Info for this Device
510(K) Number	K040586
Device Name	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Applicant	RHIGENE, INC. 12061 TEJON ST. WESTMINSTER, CO 80234 US Other 510(k) Applications for this Company
Contact	NANCI DEXTER 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	03/05/2004
Decision Date	03/22/2004
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