FDA 510(k) Application Details - K110182

Device Classification Name	Enzyme Immunoassay, Cannabinoids   More FDA Info for this Device
510(K) Number	K110182
Device Name	Enzyme Immunoassay, Cannabinoids
Applicant	Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. SUITE F GAITHERSBURG, MD 20878 US Other 510(k) Applications for this Company
Contact	Joe Shia 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	01/21/2011
Decision Date	05/20/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review