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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 K915371
Device Name COCAINE METABOLITE EIA TEST
Applicant
Diagnostic Reagents, Inc.
3255-4 Scott Blvd.
Suite 102
Santa Clara,  CA  95054
Applicant Contact YUH-GENG TSAY
Correspondent
Diagnostic Reagents, Inc.
3255-4 Scott Blvd.
Suite 102
Santa Clara,  CA  95054
Correspondent Contact YUH-GENG TSAY
Regulation Number862.3250
Classification Product Code
DIO  
Date Received11/27/1991
Decision Date 12/18/1991
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
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