FDA 510(k) Application Details - K034013

Device Classification Name	Antinuclear Antibody, Antigen, Control   More FDA Info for this Device
510(K) Number	K034013
Device Name	Antinuclear Antibody, Antigen, Control
Applicant	CORGENIX, 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	866.5100   More FDA Info for this Regulation Number
Classification Product Code	LKJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/24/2003
Decision Date	01/08/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review