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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas Chromatography, Methamphetamine
510(k) Number K080381
Device Name QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE 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 Number862.3610
Classification Product Code
LAF  
Date Received02/13/2008
Decision Date 06/25/2008
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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