FDA 510(k) Application Details - K962734

Device Classification Name	Enzyme Immunoassay, Benzodiazipine   More FDA Info for this Device
510(K) Number	K962734
Device Name	Enzyme Immunoassay, Benzodiazipine
Applicant	BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 CONCORD, CA 94524-4117 US Other 510(k) Applications for this Company
Contact	BETSY SOARES-MADDOX 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	07/15/1996
Decision Date	12/10/1996
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