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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK230038
Test Name Wondfo USA Co., Ltd, Wondfo Pregnancy Test  
Manufacturer NameGuangzhou Decheng Biotechnology Co., Ltd.
Consumer Information Phone Number1(888)444-3657
Test TypeUrine hCG by visual color comparison tests
Effective Date12/06/2023
Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K230038
Device Name MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)
Applicant
Guangzhou Decheng Biotechnology Co., Ltd.
Rm. 107/218/212/405, Bldg. 2, # 68,
1st Nanxiang Rd., Science City, Huangpu District
Guangzhou,  CN 510000
Applicant Contact Weifang Liu
Correspondent
Lsi International
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.1155
Classification Product Code
LCX  
Date Received01/06/2023
Decision Date 02/28/2023
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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