FDA 510(k) Application Details - K991252

Device Classification Name	Radioimmunoassay, Total Triiodothyronine   More FDA Info for this Device
510(K) Number	K991252
Device Name	Radioimmunoassay, Total Triiodothyronine
Applicant	TOSOH MEDICS, INC. 347 OYSTER POINT BLVD., SUITE 201 SAN FRANCISCO, CA 94080 US Other 510(k) Applications for this Company
Contact	LOIS NAKAYAMA 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	04/13/1999
Decision Date	05/11/1999
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