FDA 510(k) Application Details - K020136

Device Classification Name	Enzyme Immunoassay, Barbiturate   More FDA Info for this Device
510(K) Number	K020136
Device Name	Enzyme Immunoassay, Barbiturate
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	862.3150   More FDA Info for this Regulation Number
Classification Product Code	DIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/15/2002
Decision Date	03/20/2002
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