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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 K232864
Device Name EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
Applicant
Nantong Egens Biotechnology Co., Ltd.
No 1692 Xinghu Ave.
Nantong Economy & Technology Development Zone
Nantong,  CN 226010
Applicant Contact Ouweijun .
Correspondent
Lsi International
504e Diamond Ave.
Suite H
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.1155
Classification Product Code
LCX  
Date Received09/15/2023
Decision Date 01/26/2024
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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