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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Opiates, Over The Counter
510(k) Number K234006
Device Name AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test
Applicant
Allsource Screening Solutions
1401 Pontiac Court
Export,  PA  15632
Applicant Contact Peter O'Connor
Correspondent
LSI International, Inc.
504 E Diamond Ave.
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3650
Classification Product Code
NGL  
Date Received12/19/2023
Decision Date 03/21/2024
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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