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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzyme immunoassay, amphetamine
510(k) Number K231137
Device Name Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
Applicant
Xenta Biomedical Science Co., Ltd.
Building C5, 9th Floor, Rm 901, No. 11 Kaiyuan Avenue,
Huangpu District
Guangzhou,  CN 510535
Applicant Contact Huang Ling
Correspondent
Xenta Biomedical Science Co., Ltd.
Building C5, 9th Floor, Rm 901, No. 11 Kaiyuan Avenue,
Huangpu District
Guangzhou,  CN 510535
Correspondent Contact Huang Ling
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIS   DJG   DJR   JXM   LCM  
Date Received04/21/2023
Decision Date 05/19/2023
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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