FDA 510(k) Application Details - K063024

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K063024
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. SUNNYVALE, CA 94085-2917 US Other 510(k) Applications for this Company
Contact	MARIE LIN 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	10/02/2006
Decision Date	10/30/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review