FDA 510(k) Application Details - K011499

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K011499
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	SUN BIOMEDICAL LABORATORIES, INC. 604 VPR CENTER 1001 LOWER LANDING RD. BLACKWOOD, NJ 08012 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	05/15/2001
Decision Date	07/17/2001
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