FDA 510(k) Application Details - K981314

Device Classification Name	Enzyme Immunoassay, Methadone   More FDA Info for this Device
510(K) Number	K981314
Device Name	Enzyme Immunoassay, Methadone
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	862.3620   More FDA Info for this Regulation Number
Classification Product Code	DJR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/1998
Decision Date	09/04/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review