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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 (5-Panel)  
Manufacturer NameSafecare Biotech (Hangzhou) Co., Ltd.
Consumer Information Phone Number1(800)305-5614
Test TypeOxycodone
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.
Bldg. 2/203 #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
Predetermined Change
Control Plan Authorized		 No
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