FDA 510(k) Application Details - K071219

Device Classification Name	Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)   More FDA Info for this Device
510(K) Number	K071219
Device Name	Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
Applicant	ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 US Other 510(k) Applications for this Company
Contact	EWA NADOLCZAK Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	MVJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2007
Decision Date	12/06/2007
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