FDA 510(k) Application Details - K991610

Device Classification Name	Thyroglobulin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K991610
Device Name	Thyroglobulin, Antigen, Antiserum, Control
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	DDC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/10/1999
Decision Date	06/25/1999
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