FDA 510(k) Application Details - K151478

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K151478
Device Name	Enzyme Immunoassay, Opiates
Applicant	GUANGZHOU WONDFO BIOTECH CO., LTD. WONDFO SCIENTECH PARK, SOUTH CHINA UNIV. OF TECHNOLOGY GUANGZHOU 510641 CN Other 510(k) Applications for this Company
Contact	BEN CHEN Other 510(k) Applications for this Contact
Regulation Number	862.3650   More FDA Info for this Regulation Number
Classification Product Code	DJG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2015
Decision Date	07/01/2015
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