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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberCR240759
Test Name Wondfo USA Co., Ltd., HORMONElife Ultra Accurate FSH Test Strip  
Manufacturer NameGuangzhou Wondfo Biotech Co., Ltd.
Consumer Information Phone Number1(888)444-3657
Test TypeFollicle stimulating hormone (FSH)
Effective Date01/13/2025
Device NameHORMONElife™ Ultra Accurate FSH Test Strip
510(K) Exempt NumberCR240759
Device Classification NameTest, Follicle Stimulating Hormone (Fsh), Over The Counter
Product CodeNGA
Regulation Number862.1300
Panel Name Clinical Chemistry
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
# 8 lizhishan rd. science city
guangzhou,  51066 3
Contactkaiyu xiao
Date Received12/18/2024
Decision Date 01/13/2025
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