FDA 510(k) Application Details - K063545

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K063545
Device Name	Enzyme Immunoassay, Opiates
Applicant	ALFA SCIENTIFIC DESIGNS, INC. 13200 GREGG ST. POWAY, CA 92064 US Other 510(k) Applications for this Company
Contact	DAITING RONG 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	11/24/2006
Decision Date	05/07/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review