FDA 510(k) Application Details - K972586

Device Classification Name	Radioimmunoassay, Thyroid-Stimulating Hormone   More FDA Info for this Device
510(K) Number	K972586
Device Name	Radioimmunoassay, Thyroid-Stimulating Hormone
Applicant	TOSOH MEDICS, INC. 373 VINTAGE PARK DR. SUITE D FOSTER CITY, CA 94404 US Other 510(k) Applications for this Company
Contact	LORI ROBINSON Other 510(k) Applications for this Contact
Regulation Number	862.1690   More FDA Info for this Regulation Number
Classification Product Code	JLW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/1997
Decision Date	08/29/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review