FDA 510(k) Application Details - K112395

Device Classification Name	Radioimmunoassay, Tricyclic Antidepressant Drugs   More FDA Info for this Device
510(K) Number	K112395
Device Name	Radioimmunoassay, Tricyclic Antidepressant Drugs
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	862.3910   More FDA Info for this Regulation Number
Classification Product Code	LFG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/19/2011
Decision Date	09/09/2011
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