FDA 510(k) Application Details - K060810

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K060810
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	IND DIAGNOSTIC INC. 1629 FOSTERS WAY DELTA, BC V3M 6S7 CA Other 510(k) Applications for this Company
Contact	JASON PENG Other 510(k) Applications for this Contact
Regulation Number	862.3100   More FDA Info for this Regulation Number
Classification Product Code	DKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/24/2006
Decision Date	08/07/2006
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