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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thin Layer Chromatography, Methamphetamine
510(k) Number K010226
Device Name VERDICT -II METHAMPHETAMINE
Applicant
Medtox Diagnostics, Inc.
1238 Anthony Rd.
Burlington,  NC  27215
Applicant Contact MICHEAL TURANCHIK
Correspondent
Medtox Diagnostics, Inc.
1238 Anthony Rd.
Burlington,  NC  27215
Correspondent Contact MICHEAL TURANCHIK
Regulation Number862.3610
Classification Product Code
DJC  
Date Received01/24/2001
Decision Date 06/01/2001
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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