FDA 510(k) Application Details - K123080

Device Classification Name	Enzyme Immunoassay, Benzodiazipine   More FDA Info for this Device
510(K) Number	K123080
Device Name	Enzyme Immunoassay, Benzodiazipine
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	862.3170   More FDA Info for this Regulation Number
Classification Product Code	JXM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2012
Decision Date	11/29/2012
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