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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberCR230719
Test Name Wondfo USA Co., Ltd., BABYlife Ultra Accurate Follicle Stimulating Hormone (FSH) Test Strip  
Manufacturer NameGuangzhou Wondofo Biotech Co., Ltd.
Consumer Information Phone Number(888)444-3657
Test TypeFollicle stimulating hormone (FSH)
Effective Date12/19/2023
Device NameBABYlife Ultra Accurate Follicle Stimulating Hormone (FSH) Test Strip
510(K) Exempt NumberCR230719
Device Classification NameTest, Follicle Stimulating Hormone (Fsh), Over The Counter
Product CodeNGA
Regulation Number862.1300
Panel Name Clinical Chemistry
Applicant
Guangzhou Wondofo Biotech Co., Ltd.
no. 8 lizhishan road science c
luogang district
guangzhou,  51066 3
Contactkaiyu xiao
Date Received10/26/2023
Decision Date 12/19/2023
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