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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, Opiates
510(k) Number K220046
Device Name Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11
Applicant
Shenzhen Superbio Technology Co., Ltd.
Bldg. B, Xinzheng, 71 Area,
Xin'An Sub-District, Bao’An
Shenzhen,  CN 518101
Applicant Contact Wenhau Yan
Correspondent
Lsi
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Code
KHO  
Date Received01/05/2022
Decision Date 12/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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