FDA 510(k) Application Details - K102428

Device Classification Name	Enzyme Immunoassay, Cannabinoids   More FDA Info for this Device
510(K) Number	K102428
Device Name	Enzyme Immunoassay, Cannabinoids
Applicant	HIEN HELEN NGUYEN 1810 OAKLAND RD., STE E SAN JOSE, CA 95131 US Other 510(k) Applications for this Company
Contact	HIEN NGUYEN Other 510(k) Applications for this Contact
Regulation Number	862.3870   More FDA Info for this Regulation Number
Classification Product Code	LDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/2010
Decision Date	04/18/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review