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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 K240351
Device Name FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)
Applicant
Assure Tech LLC
1521 Concord Pike, Suite 201
Wilmington,  DE  19803
Applicant Contact Allen Chen
Correspondent
LSI International Inc
504E Diamond Ave., Suite H
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3650
Classification Product Code
NGL  
Date Received02/05/2024
Decision Date 03/06/2024
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
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