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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 K960187
Device Name COCAINE METABOLITE EIA TEST
Applicant
Diagnostic Reagents, Inc.
601 California Ave.
Sunnyvale,  CA  94086
Applicant Contact YUH-GENG TSAY
Correspondent
Diagnostic Reagents, Inc.
601 California Ave.
Sunnyvale,  CA  94086
Correspondent Contact YUH-GENG TSAY
Regulation Number862.3250
Classification Product Code
DIO  
Date Received01/16/1996
Decision Date 04/02/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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