FDA 510(k) Application Details - K113501

Device Classification Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites   More FDA Info for this Device
510(K) Number	K113501
Device Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant	AMEDITECH, INC. 10340 CAMINO SANTA FE SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	BRETT CASEY Other 510(k) Applications for this Contact
Regulation Number	862.3250   More FDA Info for this Regulation Number
Classification Product Code	DIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/2011
Decision Date	12/05/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review