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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 K220451
Device Name Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
Applicant
Randox Laboratories Limited
55 Diamond Road
Crumlin,  GB BT29 4Qy
Applicant Contact Karena Shaw
Correspondent
Randox Laboratories Limited
55 Diamond Road
Crumlin,  GB BT29 4Qy
Correspondent Contact Karena Shaw
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DJC   DJR   JJE   JXM  
Date Received02/17/2022
Decision Date 10/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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