FDA 510(k) Application Details - K131232

Device Classification Name	Enzyme Immunoassay, Methadone   More FDA Info for this Device
510(K) Number	K131232
Device Name	Enzyme Immunoassay, Methadone
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	862.3620   More FDA Info for this Regulation Number
Classification Product Code	DJR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2013
Decision Date	05/31/2013
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