FDA 510(k) Application Details - K993485

Device Classification Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites   More FDA Info for this Device
510(K) Number	K993485
Device Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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	862.3250   More FDA Info for this Regulation Number
Classification Product Code	DIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/1999
Decision Date	12/27/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review