FDA 510(k) Application Details - K954496

Device Classification Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites   More FDA Info for this Device
510(K) Number	K954496
Device Name	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant	BOEHRINGER MANNHEIM CORP. 1700 ROCKVILLE PIKE SUITE 450 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	STEVE REITZLER 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	09/27/1995
Decision Date	03/06/1996
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