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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 K231698
Device Name AllTest Fentanyl Rapid Test (Urine)
Applicant
Hangzhou AllTest Biotech Co., Ltd.
# 550, Yinhai St. Hangzhou Economic
& Technological Development Area
Hangzhou,  CN 310018
Applicant Contact Rosa Wu
Correspondent
LSI International, Inc.
504e Diamond Ave.
Suite H
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3650
Classification Product Code
DJG  
Date Received06/12/2023
Decision Date 07/31/2023
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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