FDA 510(k) Application Details - K081378

Device Classification Name	Enzyme Immunoassay, Methadone   More FDA Info for this Device
510(K) Number	K081378
Device Name	Enzyme Immunoassay, Methadone
Applicant	Thermo Fisher Scientific 46360 FREMONT BLVD. FREMONT, CA 94538 US Other 510(k) Applications for this Company
Contact	JACK ROGERS 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	05/16/2008
Decision Date	01/14/2009
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