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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Opiates
510(k) Number K031032
Device Name VERDICT II, PROFILE II
Applicant
Medtox Diagnostics, Inc.
1238 Anthony Rd.
Burlington,  NC  27215
Applicant Contact ALAN MORRIS
Correspondent
Medtox Diagnostics, Inc.
1238 Anthony Rd.
Burlington,  NC  27215
Correspondent Contact ALAN MORRIS
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DIO   DJC   LDJ  
Date Received04/01/2003
Decision Date 07/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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