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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK233417
Test Name McKesson Medical-Surgical Inc., McKesson Consult Fentanyl Urine Test Cassette  
Manufacturer NameHangzhou AllTest Biotech Co.,Ltd
Consumer Information Phone Number(800)777-4908
Test TypeFentanyl
Effective Date12/22/2023
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 Street
Hangzhou,  CN 310018
Applicant Contact Rosa Wu
Correspondent
LSI International, Inc.
504 East 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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