FDA 510(k) Application Details - K000755

Device Classification Name	Anti-Sm Antibody, Antigen And Control   More FDA Info for this Device
510(K) Number	K000755
Device Name	Anti-Sm 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	DAVE KOLESAR Other 510(k) Applications for this Contact
Regulation Number	866.5100   More FDA Info for this Regulation Number
Classification Product Code	LKP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/08/2000
Decision Date	05/09/2000
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