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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 K250741
Device Name Evidence MultiSTAT DOA Urine MultiPlex
Applicant
Randox Laboratories Limited
55 Diamond Rd.
Crumlin,  GB BT29 4QY
Applicant Contact Karena Shaw
Correspondent
Randox Laboratories Limited
55 Diamond Rd.
Crumlin,  GB BT29 4QY
Correspondent Contact Karena Shaw
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DIO   DIS   DJC   DJR   DKZ  
JXM   LCM   LDJ  
Date Received03/11/2025
Decision Date 01/23/2026
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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