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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, cannabinoid, over the counter
510(k) Number K191924
Device Name SAFECARE® THC Urine Strip Test
Applicant
Safecare Biotech (Hangzhou) Co., Ltd.
Building 2/203 No.18 Haishu Rd., Cangqian Sub-district,
Yuhang District
Hangzhou,  CN 311121
Applicant Contact Alex Qiu
Correspondent
LSI International
504 E Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3870
Classification Product Code
NFW  
Date Received07/18/2019
Decision Date 08/16/2019
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
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