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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, test, pregnancy, hcg, over the counter
510(k) Number K233624
Device Name HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx
Applicant
Hangzhou Aichek Medical Technology Co., Ltd.
3rd Floor, Building 9, Hexiang Technology Center,
Xiasha Street, Qiantang District
Hangzhou,  CN 310018
Applicant Contact Lisa Liu
Correspondent
Shanghai Sungo Management Consulting Co., Ltd.
14th Floor, 1500# Century Avenue
Shanghai,  CN 200122
Correspondent Contact Dylan Wu
Regulation Number862.1155
Classification Product Code
LCX  
Subsequent Product Code
JHI  
Date Received11/13/2023
Decision Date 04/12/2024
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
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