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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK150022
Test Name Winx Health Inc., winx health early pregnancy tests  
Manufacturer NameGuangzhou Wondfo Biotech Co., Ltd.
Consumer Information Phone Number1(888)298-2620
Test TypeUrine hCG by visual color comparison tests
Effective Date12/04/2024
Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K150022
Device Name Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
Wondfo Scientech Park, S. China Univ. Of Technology
Guangzhou,  CN 510641
Applicant Contact Ben Chen
Correspondent
LSI International, Inc.
504 E. Diamond Ave. Suite F
Gaithersburg,  MD  20878
Correspondent Contact Joe Shia
Regulation Number862.1155
Classification Product Code
LCX  
Subsequent Product Code
JHI  
Date Received01/06/2015
Decision Date 08/07/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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