FDA 510(k) Application Details - K972190

Device Classification Name	System, Test, Thyroid Autoantibody   More FDA Info for this Device
510(K) Number	K972190
Device Name	System, Test, Thyroid Autoantibody
Applicant	AMERICAN LABORATORY PRODUCTS CO., LTD. P.O. BOX 451 WINDHAM, NH 03087 US Other 510(k) Applications for this Company
Contact	RICHARD CONLEY 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	05/19/1997
Decision Date	07/14/1997
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