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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
Applicant
Hangzhou AllTest Biotech Co., Ltd.
#550 Yinhai St.
Hangzhou,  CN 310018
Applicant Contact Rosa Wu
Correspondent
LSI International, Inc.
504 E Diamond Ave.
Suite H
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3650
Classification Product Code
NGL  
Subsequent Product Code
DJG  
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
Predetermined Change
Control Plan Authorized		 No
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