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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 K220999
Device Name Hipro Glycosylated Hemoglobin (HbA1c) Test System
Applicant
Shijiazhuang Hipro Biotechnology Co., Ltd.
# 3 Bldg., Block C, Fangyi Science Park,
# 313 Zhujiangdadao Rd., Hi-Tech Zone
Shijiazhuang,  CN 050000
Applicant Contact Emily No Last Name Provided
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A,Zhongguan Times Sq.,
Liuxian Ave., Xili Town, Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Hanson Chen
Regulation Number862.1373
Classification Product Code
PDJ  
Subsequent Product Code
LCP  
Date Received04/04/2022
Decision Date 09/12/2024
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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