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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberCR250085
Test Name Wondfo USA Co., Ltd., HORMONElife PdG Urine Test Strip  
Manufacturer NameGuangzhou Wondfo Biotech Co., Ltd.
Consumer Information Phone Number1(888)444-3657
Test TypePregnanediol Glucuronide
Effective Date04/07/2025
Device NameHORMONElife PdG Urine Test Strip
510(K) Exempt NumberCR250085
Device Classification NameImmunoassay, Pregnanediol Glucuronide, Over The Counter
Product CodeQKE
Regulation Number862.1620
Panel Name Clinical Chemistry
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
# 8 lizhishan rd. science city
guangzhou,  51066 3
Contactkaiyu xiao
Date Received02/20/2025
Decision Date 04/07/2025
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