FDA 510(k) Application Details - K153465

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K153465
Device Name	Enzyme Immunoassay, Amphetamine
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	862.3100   More FDA Info for this Regulation Number
Classification Product Code	DKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/01/2015
Decision Date	03/31/2016
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