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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK182654
Test Name DEUS VULT LLC, Preferred Med Supply Multi-Panel Drug Test Dip Card  
Manufacturer NameSafecare Biotech (Hangzhou) Co., Ltd.
Consumer Information Phone Number(866)876-6355
Test TypeMorphine
Effective Date03/18/2020
Device Classification Name Test, Methamphetamine, Over The Counter
510(k) Number K182654
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 Number862.3610
Classification Product Code
NGG  
Subsequent Product Codes
NFT   NFV   NFW   NFY   NGI  
NGL   NGM   PTG   PTH   QAW   QBF  
Date Received09/25/2018
Decision Date 11/19/2018
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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