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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberCR250101
Test Name Wondfo USA Co., Ltd., HORMONElife Ultra Accurate Ovulation Test Strip  
Manufacturer NameWondfo USA Co., Ltd.
Consumer Information Phone Number1(888)444-3657
Test TypeLuteinizing hormone (LH)
Effective Date04/08/2025
Device NameHORMONElife Ultra Accurate Ovulation Test Strip
510(K) Exempt NumberCR250101
Device Classification NameTest, Luteinizing Hormone (Lh), Over The Counter
Product CodeNGE
Regulation Number862.1485
Panel Name Clinical Chemistry
Applicant
Wondfo USA Co., Ltd.
890 remington blvd.
bolingbrook,  IL  60440
Contactkaiyu xiao
Date Received03/04/2025
Decision Date 04/08/2025
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