FDA 510(k) Application Details - K053422

Device Classification Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites   More FDA Info for this Device
510(K) Number	K053422
Device Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant	AMERICAN BIO MEDICA CORP. 9110 RED BRANCH ROAD SUITE B COLUMBIA, MD 21045 US Other 510(k) Applications for this Company
Contact	HENRY WELLS 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	12/08/2005
Decision Date	06/15/2006
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