FDA 510(k) Application Details - K072458

Device Classification Name	Radioimmunoassay, Thyroid-Stimulating Hormone   More FDA Info for this Device
510(K) Number	K072458
Device Name	Radioimmunoassay, Thyroid-Stimulating Hormone
Applicant	GOLDEN BRIDGE INTERNATIONAL, INC. 9700 HARBOUR PL. SUITE 129 MUKILTEO, WA 98275 US Other 510(k) Applications for this Company
Contact	XIAOPING ZHANG 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	08/31/2007
Decision Date	04/10/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review