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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK182530
Test Name Shenzhen Superbio Technology Co., Ltd, U-CATCH PLUS Multi-Drug Test Cup  
Manufacturer NameShenzhen Bioeasy Biotechnology Co., Ltd.
Consumer Information Phone Number1(888)571-2286
Test TypeOxycodone
Effective Date01/11/2022
Device Classification Name Test, Amphetamine, Over The Counter
510(k) Number K182530
Device Name BIOEASY Multi-Drug Test Cup
Applicant
Shenzhen Bioeasy Biotechnology Co., Ltd.
#2-1,Liuxian 1st Rd.,Xin'An Sub-District
Shenzhen,  CN 518101
Applicant Contact Wenhau Yan
Correspondent
Lsi
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   NGI  
NGL   NGM   PTG   PTH   QAW   QBF  
Date Received09/14/2018
Decision Date 11/09/2018
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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