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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, Tracrolimus
510(k) Number K203833
Device Name Tacrolimus Assay Kit
Applicant
Shanghai Genext Medical Technology Co., Ltd.
Rm1101, 11th Floor, Bldg. 2, Pujiang Hi-Tech Plaza, #2388
Chenhang Rd. Pujiang Town
Shanghai,  CN 201114
Applicant Contact Kimmy Zong
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd., Bldg. 1 Suite 300
Austin,  TX  78746
Correspondent Contact Giselle Zhang
Regulation Number862.1678
Classification Product Code
MLM  
Date Received12/30/2020
Decision Date 01/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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