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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 K222667
Device Name Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
Applicant
Vivachek Biotech (Hangzhou) Co., Ltd.
Level 2, Block 2, 146 E. Chaofeng Rd.
Yuhang Economy Development Zone
Hangzhou,  CN 311100
Applicant Contact Jessica Chen
Correspondent
Lsi International
540 E Diamond Ave.,
Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3100
Classification Product Code
NFT  
Subsequent Product Codes
LCM   NFV   NFW   NFY   NGG  
NGL   PTG   PTH   QAW   QBF  
Date Received09/06/2022
Decision Date 11/10/2022
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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