FDA 510(k) Application Details - K972032

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K972032
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	SUN BIOMEDICAL LABORATORIES, INC. 2040 FAIRFAX AVE. CHERRY HILL, NJ 08003 US Other 510(k) Applications for this Company
Contact	MING SUN 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	06/02/1997
Decision Date	08/12/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review