FDA 510(k) Application Details - K162698

Device Classification Name	Radioimmunoassay, Thyroid-Stimulating Hormone   More FDA Info for this Device
510(K) Number	K162698
Device Name	Radioimmunoassay, Thyroid-Stimulating Hormone
Applicant	SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD NO.16, JINHUI RD, PINGSHAN NEW DISTRICT Shenzhen 518122 CN Other 510(k) Applications for this Company
Contact	Jie Rao 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	09/27/2016
Decision Date	07/14/2017
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