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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 K003845
Device Name MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP)
Applicant
Alfa Scientific Designs, Inc.
12330 Stowe Dr.
Poway,  CA  92064
Applicant Contact NAISHU WANG
Correspondent
Alfa Scientific Designs, Inc.
12330 Stowe Dr.
Poway,  CA  92064
Correspondent Contact NAISHU WANG
Regulation Number862.3610
Classification Product Code
LAF  
Date Received12/12/2000
Decision Date 05/29/2001
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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