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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK181768
Test Name BTNX, Inc. Rapid Response Drug Screening Cup  
Manufacturer NameAssure Tech (Hangzhou) Co., Ltd.
Consumer Information Phone Number(888)339-9964
Test TypeAmphetamines
Effective Date06/28/2019
Device Classification Name test, amphetamine, over the counter
510(k) Number K181768
Device Name AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
Applicant
Assure Tech (Hangzhou) Co., Ltd.
2nd-5th Floor, Building 4, No. 1418-50, Moganshan Road
Gongshu District
Hangzhou,  CN 310011
Applicant Contact Shisheng Ling
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   NGL  
NGM   PTG   PTH   QAW   QBF  
Date Received07/03/2018
Decision Date 08/20/2018
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
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