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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK202453
Test Name Lendas, UAB, Exploro Highly Sensitive Urine Drug Test (12-Panel)  
Manufacturer NameSafecare Biotech(Hangzhou)Co.,Ltd.
Consumer Information Phone Number1(800)305-5614
Test TypeMethadone metabolite (EDDP)
Effective Date06/21/2024
Device Classification Name Test, Amphetamine, Over The Counter
510(k) Number K202453
Device Name SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
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 Number862.3100
Classification Product Code
NFT  
Subsequent Product Codes
NFV   NFW   NFY   NGG   NGI  
NGL   NGM   PTG   PTH   QAW   QBF  
Date Received08/27/2020
Decision Date 03/24/2021
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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