FDA 510(k) Application Details - K010239

Device Classification Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites   More FDA Info for this Device
510(K) Number	K010239
Device Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant	TECO DIAGNOSTICS 4925 EAST HUNTER AVE. ANAHEIM, CA 92807 US Other 510(k) Applications for this Company
Contact	DINDO CARRILLO 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	01/25/2001
Decision Date	06/25/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review