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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK181768
Test Name 12 Panel Now (DBA) Hospital Connect Inc, 12panel now Panel Dip Tests  
Manufacturer NameAssure Tech (Hangzhou) Co., Ltd.
Consumer Information Phone Number1(888)936-6627
Test TypeTricyclic antidepressants
Effective Date05/03/2019
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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