FDA 510(k) Application Details - K971834

Device Classification Name	Immunochemical, Thyroglobulin Autoantibody   More FDA Info for this Device
510(K) Number	K971834
Device Name	Immunochemical, Thyroglobulin Autoantibody
Applicant	MONOBIND 729 WEST 16TH ST., C-4 COSTA MESA, CA 92627 US Other 510(k) Applications for this Company
Contact	FREDERICK R JEROME Other 510(k) Applications for this Contact
Regulation Number	866.5870   More FDA Info for this Regulation Number
Classification Product Code	JNL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/19/1997
Decision Date	07/03/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review