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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 K012585
Device Name AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE
Applicant
Ameditech, Inc.
10340 Camino Santa Fe
Suites F-G
San Diego,  CA  92121
Applicant Contact JOHN WU
Correspondent
Ameditech, Inc.
10340 Camino Santa Fe
Suites F-G
San Diego,  CA  92121
Correspondent Contact JOHN WU
Regulation Number862.3610
Classification Product Code
LAF  
Date Received08/10/2001
Decision Date 11/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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