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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 K170049
Device Name AssureTech Panel Dip Test, AssureTech Quick Cup Test
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  
Date Received01/05/2017
Decision Date 05/02/2017
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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