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U.S. Department of Health and Human Services

OTC - Over The Counter

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Document NumberK201120
Test Name Omega Laboratories, Omega Urine 9 Panel Drug Key Test Cup  
Manufacturer NameSafecare Biotech(Hangzhou)Co.,Ltd.
Consumer Information Phone Number(800)665-5569
Test TypeOxycodone
Effective Date07/10/2020
Device Classification Name test, amphetamine, over the counter
510(k) Number K201120
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 Received04/27/2020
Decision Date 05/27/2020
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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