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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemoglobin A1c Test System
510(k) Number K242911
Device Name Medconn Glycated Hemoglobin Test system
Applicant
Shanghai Medconn Medical Technology Co., Ltd.
#1018 Weichang Rd.
Shanyang Town, Jinshan District
Shanghai,  CN 201508
Applicant Contact Judan Guan
Correspondent
Guangdong Grzan Group Co., Ltd.
Rm.103-108, 1st Floor, Block B, Bldg. 2, Bangkai Science And
Technology Park, Guanguang Rd., Guangming District
Shenzhen,  CN 518107
Correspondent Contact Jessie Mu
Regulation Number862.1373
Classification Product Code
PDJ  
Subsequent Product Code
LCP  
Date Received09/24/2024
Decision Date 06/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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