FDA 510(k) Application Details - K973075

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K973075
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 BRANCHBURG, NJ 08876-3771 US Other 510(k) Applications for this Company
Contact	JAMES W HAYNES Other 510(k) Applications for this Contact
Regulation Number	862.3100   More FDA Info for this Regulation Number
Classification Product Code	DKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/1997
Decision Date	10/09/1997
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