FDA 510(k) Application Details - K071489

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K071489
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	Tianjin New Bay Bioresearch Co., Ltd. 3108 AVENIDA OLMEDA CARLSBAD, CA 92009 US Other 510(k) Applications for this Company
Contact	ARMANDO A TORRESCANO Other 510(k) Applications for this Contact
Regulation Number	862.3100   More FDA Info for this Regulation Number
Classification Product Code	DKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2007
Decision Date	03/28/2008
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