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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Tricyclic Antidepressant Drugs
510(k) Number K011545
Device Name VERDICT -II TCA, VERDICT-II MTD
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 Number862.3910
Classification Product Code
LFG  
Subsequent Product Code
DJR  
Date Received05/18/2001
Decision Date 06/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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