FDA 510(k) Application Details - K031497

Device Classification Name	Thin Layer Chromatography, Metamphetamine   More FDA Info for this Device
510(K) Number	K031497
Device Name	Thin Layer Chromatography, Metamphetamine
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	862.3610   More FDA Info for this Regulation Number
Classification Product Code	DJC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2003
Decision Date	10/17/2003
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