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Document NumberK240698
Test Name EZCHECK LLC, EZCHECK Multi-Drug Urine Test Dipcard  
Manufacturer NameGuangzhou Decheng Biotechnology Co., Ltd.
Consumer Information Phone Number(866)583-6608
Test TypeBuprenorphine
Effective Date10/28/2024
Device Classification Name Enzyme Immunoassay, Opiates
510(k) Number K240698
Device Name Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard
Applicant
Guangzhou Decheng Biotechnology Co., Ltd.
Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road
Science City, Huangpu District
Guangzhou,  CN 510663
Applicant Contact Mango Huang
Correspondent
Guangzhou Decheng Biotechnology Co., Ltd.
Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road
Science City, Huangpu District
Guangzhou,  CN 510663
Correspondent Contact Mango Huang
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DIO   DIS   DJC   DJR   DKZ  
JXM   JXN   LCM   LDJ   LFG   NFT  
NFV   NFW   NFY   NGG   NGL   NGM  
PTG   PTH   QAW   QBF  
Date Received03/14/2024
Decision Date 05/10/2024
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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