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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 K231904
Device Name Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
Applicant
Co-Innovation Biotech Co.,Ltd.
No.9 Baihe 3 Street,
Economic And Technological Development East Zone,
Guangzhou,  CN 510530
Applicant Contact Hong Feng
Correspondent
Co-Innovation Biotech Co.,Ltd.
No.9 Baihe 3 Street,
Economic And Technological Development East Zone,
Guangzhou,  CN 510530
Correspondent Contact Hong Feng
Regulation Number862.3650
Classification Product Code
DJG  
Date Received06/28/2023
Decision Date 03/08/2024
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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