FDA 510(k) Application Details - K021944

Device Classification Name	Enzyme Immunoassasy, Nocotine And Nicotine Metabolites   More FDA Info for this Device
510(K) Number	K021944
Device Name	Enzyme Immunoassasy, Nocotine And Nicotine Metabolites
Applicant	COZART BIOSCIENCE LTD. 45 MILTON PARK ABINGDON OXFORDSHIRE OX14 4RU OX14 4RU GB Other 510(k) Applications for this Company
Contact	ROBERTO LIDDI Other 510(k) Applications for this Contact
Regulation Number	862.3220   More FDA Info for this Regulation Number
Classification Product Code	MKU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/13/2002
Decision Date	05/14/2003
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