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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.
Building B, Xinzheng, 71 Area,
Xin'an Sub-District, Bao’an
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
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
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