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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 K233417
Device Name AllTest Fentanyl Urine Test Cassette
Hangzhou AllTest Biotech Co.,Ltd
#550, Yinhai Street
Hangzhou,  CN 310018
Applicant Contact Rosa Wu
LSI International, Inc.
504 East Diamond Ave., Suite H
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3650
Classification Product Code
Subsequent Product Code
Date Received10/10/2023
Decision Date 10/26/2023
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