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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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, Bldg. 4, # 1418-50, Moganshan Rd.,
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
Predetermined Change
Control Plan Authorized		 No
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