FDA 510(k) Application Details - K962795

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K962795
Device Name	Enzyme Immunoassay, Opiates
Applicant	BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. CONCORD, CA 94524 US Other 510(k) Applications for this Company
Contact	BETSY SOARES-MADDOX Other 510(k) Applications for this Contact
Regulation Number	862.3650   More FDA Info for this Regulation Number
Classification Product Code	DJG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/1996
Decision Date	10/30/1996
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