FDA 510(k) Application Details - K082898

Device Classification Name	Test, Opiates, Over The Counter   More FDA Info for this Device
510(K) Number	K082898
Device Name	Test, Opiates, Over The Counter
Applicant	AMEDICA BIOTECH, INC. 28301 INDUSTRIAL BLVD SUITE K HAYWARD, CA 94545 US Other 510(k) Applications for this Company
Contact	Jeff Chen Other 510(k) Applications for this Contact
Regulation Number	862.3650   More FDA Info for this Regulation Number
Classification Product Code	NGL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2008
Decision Date	12/19/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review