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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 K252684
Device Name Labcorp Fentanyl Urine Visual Test
Applicant
Medtox Diagnostics, Inc.
1238 Anthony Rd.
Burlington,  NC  27215
Applicant Contact Elizabeth Brock
Correspondent
Medtox Diagnostics, Inc.
1238 Anthony Rd.
Burlington,  NC  27215
Correspondent Contact Elizabeth Brock
Regulation Number862.3650
Classification Product Code
DJG  
Date Received08/25/2025
Decision Date 01/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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