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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK193480
Test Name Bioeasy USA, Inc., S-TRUST SE Multi-Drug Test Cup  
Manufacturer NameShenzhen Bioeasy Biotechnology Co.,Ltd.
Consumer Information Phone Number1(844)666-0668
Test TypePhencyclidine (PCP)
Effective Date05/27/2022
Device Classification Name Test, Opiates, Over The Counter
510(k) Number K193480
Device Name BIOEASY Multi-Drug Test Cup
Applicant
Shenzhen Bioeasy Biotechnology Co.,Ltd.
No.2-1, Liuxian 1st Road, Xin'an Sub-District
Shenzhen,  CN 518101
Applicant Contact Wenhau Yan
Correspondent
LSI
504E Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3650
Classification Product Code
NGL  
Subsequent Product Codes
NFT   NFV   NFW   NFY   NGG  
NGI   NGM   PTG   PTH   QAW   QBF  
Date Received12/16/2019
Decision Date 01/31/2020
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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