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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagents, Test, Tetrahydrocannabinol
510(k) Number K982211
Device Name PROFILE-II MODEL 600582
Applicant
Medtox Diagnostics, Inc.
1238 Anthony Rd.
Burlington,  NC  27215
Applicant Contact MICHAEL TURANCHIK
Correspondent
Medtox Diagnostics, Inc.
1238 Anthony Rd.
Burlington,  NC  27215
Correspondent Contact MICHAEL TURANCHIK
Regulation Number862.3870
Classification Product Code
DKE  
Subsequent Product Codes
DIO   DJG   DKZ   LCM  
Date Received06/23/1998
Decision Date 07/29/1998
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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