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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberCR250084
Test Name Wondfo USA Co., Ltd., HORMONElife Ovulation Test Strip  
Manufacturer NameGuangzhou Wondfo Biotech Co., Ltd.
Consumer Information Phone Number1(888)444-3657
Test TypeOvulation test (LH) By visual color comparison
Effective Date04/03/2025
Device NameHORMONElife Ovulation Test Strip
510(K) Exempt NumberCR250084
Device Classification NameTest, Luteinizing Hormone (Lh), Over The Counter
Product CodeNGE
Regulation Number862.1485
Panel Name Toxicology
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
# 8 lizhishan rd. science city
guangzhou,  51066 3
Contactkaiyu xiao
Date Received02/20/2025
Decision Date 04/03/2025
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