FDA 510(k) Application Details - K040200

Device Classification Name	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls   More FDA Info for this Device
510(K) Number	K040200
Device Name	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Applicant	RHIGENE, INC. 455 STATE ST., SUITE 104 DES PLAINES, IL 60016 US Other 510(k) Applications for this Company
Contact	YUSUKE KOBE Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	LJM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/29/2004
Decision Date	03/04/2004
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