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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 K062929
Device Name QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA
Applicant
Quest Diagnostics, Inc.
10101 Renner Blvd.
Lenexa,  KS  66219
Applicant Contact LIUMING YU
Correspondent
Quest Diagnostics, Inc.
10101 Renner Blvd.
Lenexa,  KS  66219
Correspondent Contact LIUMING YU
Regulation Number862.3250
Classification Product Code
DIO  
Date Received09/28/2006
Decision Date 12/18/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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