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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 K241394
Device Name iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
Applicant
Andon Health Co, Ltd.
No 3, Jinping St., Ya An Rd., Nankai District
Tianjin,  CN
Applicant Contact Liu Yi
Correspondent
Andon Health Co, Ltd.
No 3, Jinping St., Ya An Rd., Nankai District
Tianjin,  CN
Correspondent Contact Liu Yi
Regulation Number862.1155
Classification Product Code
LCX  
Date Received05/16/2024
Decision Date 12/20/2024
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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