FDA 510(k) Application Details - K963687

Device Classification Name	Radioimmunoassay, Total Triiodothyronine   More FDA Info for this Device
510(K) Number	K963687
Device Name	Radioimmunoassay, Total Triiodothyronine
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	862.1710   More FDA Info for this Regulation Number
Classification Product Code	CDP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/1996
Decision Date	11/08/1996
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