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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, cannabinoids
510(k) Number K232732
Device Name Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50
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 Number862.3870
Classification Product Code
LDJ  
Date Received09/07/2023
Decision Date 01/17/2024
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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