FDA 510(k) Application Details - K161044

Device Classification Name	Thin Layer Chromatography, Metamphetamine   More FDA Info for this Device
510(K) Number	K161044
Device Name	Thin Layer Chromatography, Metamphetamine
Applicant	ASSURE TECH (HANGZHOU) CO., LTD. NO. 10, XIYUANSAN RD., WESTLAKE ECONOMIC ZONE HANGZHOU 310030 CN Other 510(k) Applications for this Company
Contact	SHISHENG LING Other 510(k) Applications for this Contact
Regulation Number	862.3610   More FDA Info for this Regulation Number
Classification Product Code	DJC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/13/2016
Decision Date	07/06/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review