FDA 510(k) Application Details - K080347

Device Classification Name	Thin Layer Chromatography, Metamphetamine   More FDA Info for this Device
510(K) Number	K080347
Device Name	Thin Layer Chromatography, Metamphetamine
Applicant	TAIWAN UNISON BIOTECH, INC. 3F, NO. 22, KEDUNG 3RD ROAD CHUNAN, MIAOLI 350 TW Other 510(k) Applications for this Company
Contact	KUANG-PIN HSIUNG 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	02/08/2008
Decision Date	10/09/2008
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	Y
Expedited Review