FDA 510(k) Application Details - K022017

Device Classification Name	Anti-Rnp Antibody, Antigen And Control   More FDA Info for this Device
510(K) Number	K022017
Device Name	Anti-Rnp Antibody, Antigen And Control
Applicant	RHIGENE, INC. 455 STATE ST., SUITE 104 DES PLAINES, IL 60068 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	LKO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2002
Decision Date	08/14/2002
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