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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 K000452
Device Name SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST
Applicant
Drug Detection Devices, Ltd.
6820 Meadowridge Ct.
Suite A-7
Alpharetta,  GA  30005
Applicant Contact PATRICK BEENTJES
Correspondent
Drug Detection Devices, Ltd.
6820 Meadowridge Ct.
Suite A-7
Alpharetta,  GA  30005
Correspondent Contact PATRICK BEENTJES
Regulation Number862.3610
Classification Product Code
LAF  
Date Received02/11/2000
Decision Date 04/24/2000
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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