FDA 510(k) Application Details - K100108

Device Classification Name	Test, Opiates, Over The Counter   More FDA Info for this Device
510(K) Number	K100108
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	01/14/2010
Decision Date	04/14/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
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