FDA 510(k) Application Details - K102203

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K102203
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	CHEMTRON BIOTECH, INC. 8370 JUNIPER CREEK LANE SUITE 1-2 SAN DIEGO, CA 92126 US Other 510(k) Applications for this Company
Contact	Jane Zhang 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	08/04/2010
Decision Date	01/20/2011
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	N
Expedited Review