FDA 510(k) Application Details - K000336

Device Classification Name	Autoantibodies,Skin(Desmoglein 1 And Desmoglein 3)   More FDA Info for this Device
510(K) Number	K000336
Device Name	Autoantibodies,Skin(Desmoglein 1 And Desmoglein 3)
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	866.5660   More FDA Info for this Regulation Number
Classification Product Code	NBO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/03/2000
Decision Date	06/09/2000
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