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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Opiates, Over The Counter
510(k) Number K241100
Device Name Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard
Applicant
Co-Innovation Biotech Co., Ltd.
#9 Baihe 3 St., Economic And Technological Development
East Zone
Guangzhou,  CN 510530
Applicant Contact Hong Feng
Correspondent
Co-Innovation Biotech Co., Ltd.
#9 Baihe 3 St., Economic And Technological Development
East Zone
Guangzhou,  CN 510530
Correspondent Contact Hong Feng
Regulation Number862.3650
Classification Product Code
NGL  
Date Received04/22/2024
Decision Date 05/22/2024
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
Predetermined Change
Control Plan Authorized		 No
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