FDA 510(k) Application Details - K153597

Device Classification Name	Enzyme Immunoassay, Benzodiazipine   More FDA Info for this Device
510(K) Number	K153597
Device Name	Enzyme Immunoassay, Benzodiazipine
Applicant	HEALGEN SCIENTIFIC LLC 5213 MAPLE ST BELLAIRE, TX 77401 US Other 510(k) Applications for this Company
Contact	Jianqiu Fang Other 510(k) Applications for this Contact
Regulation Number	862.3170   More FDA Info for this Regulation Number
Classification Product Code	JXM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2015
Decision Date	05/23/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review