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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 K241741
Device Name SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
No.8 Lizhishan Road, Science City, Huangpu District
Guangzhou,  CN 510663
Applicant Contact Kaiyu Xiao
Correspondent
LSI International Inc
504E Diamond Ave., Suite H
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3650
Classification Product Code
NGL  
Date Received06/17/2024
Decision Date 07/16/2024
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
Predetermined Change
Control Plan Authorized		 No
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