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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 K240654
Device Name SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette
Applicant
Safecare Biotech (Hangzhou) Co., Ltd.
Bldg. 2/203 #18 Haishu Rd., Cangqian Sub-District
Yuhang District
Hangzhou,  CN 311121
Applicant Contact Alex Qiu
Correspondent
LSI International, Inc.
504e Diamond Ave.
Suite H
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3650
Classification Product Code
NGL  
Date Received03/07/2024
Decision Date 04/10/2024
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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