FDA 510(k) Application Details - K080872

Device Classification Name	Enzyme Immunoassay, Cannabinoids   More FDA Info for this Device
510(K) Number	K080872
Device Name	Enzyme Immunoassay, Cannabinoids
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	862.3870   More FDA Info for this Regulation Number
Classification Product Code	LDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2008
Decision Date	08/19/2008
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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