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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK180349
Test Name Premier Biotech Inc. Premier Bio-Dip  
Manufacturer NameAssure Tech (Hangzhou) Co., Ltd.
Consumer Information Phone Number(888)686-9909
Test TypeTricyclic antidepressants
Effective Date05/24/2018
Device Classification Name Test, Amphetamine, Over The Counter
510(k) Number K180349
Device Name AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
Applicant
Assure Tech (Hangzhou) Co., Ltd.
No. 10, Xiyuansan Rd., Westlake Economic Zone
Hangzhou,  CN 310030
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 Received02/08/2018
Decision Date 04/05/2018
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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