FDA 510(k) Application Details - K001352

Device Classification Name	System, Test, Systemic Lupus Erythematosus   More FDA Info for this Device
510(K) Number	K001352
Device Name	System, Test, Systemic Lupus Erythematosus
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	866.5820   More FDA Info for this Regulation Number
Classification Product Code	DHC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2000
Decision Date	04/09/2001
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