FDA 510(k) Application Details - K983174

Device Classification Name	Enzyme Immunoassay, Benzodiazipine   More FDA Info for this Device
510(K) Number	K983174
Device Name	Enzyme Immunoassay, Benzodiazipine
Applicant	ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 BRANCHBURG, NJ 08876-3771 US Other 510(k) Applications for this Company
Contact	MARIA FEIJOO Other 510(k) Applications for this Contact
Regulation Number	862.3170   More FDA Info for this Regulation Number
Classification Product Code	JXM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/1998
Decision Date	11/18/1998
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