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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Cocaine And Cocaine Metabolites
510(k) Number K935016
Device Name COCAINE METABOLITE EIA ASSAY MODIFICATION
Applicant
Diagnostic Reagents, Inc.
110 Pioneer Way
Mountain View,  CA  94041
Applicant Contact YEH-GENG TSAY
Correspondent
Diagnostic Reagents, Inc.
110 Pioneer Way
Mountain View,  CA  94041
Correspondent Contact YEH-GENG TSAY
Regulation Number862.3250
Classification Product Code
DIO  
Date Received10/18/1993
Decision Date 12/03/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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