FDA 510(k) Application Details - K151211

Device Classification Name	Enzyme Immunoassay, Barbiturate   More FDA Info for this Device
510(K) Number	K151211
Device Name	Enzyme Immunoassay, Barbiturate
Applicant	Assure Tech. Co., Ltd 2nd. Floor, Building 1, No. 10, Xiyuansan Road, Hangzhou 310030 CN Other 510(k) Applications for this Company
Contact	Eric Lin Other 510(k) Applications for this Contact
Regulation Number	862.3150   More FDA Info for this Regulation Number
Classification Product Code	DIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/2015
Decision Date	06/04/2015
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