FDA 510(k) Application Details - K033977

Device Classification Name	System, Test, Thyroid Autoantibody   More FDA Info for this Device
510(K) Number	K033977
Device Name	System, Test, Thyroid Autoantibody
Applicant	ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 US Other 510(k) Applications for this Company
Contact	MARK J KOPNITSKY Other 510(k) Applications for this Contact
Regulation Number	866.5870   More FDA Info for this Regulation Number
Classification Product Code	JZO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2003
Decision Date	03/22/2004
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