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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K222305
Device Name MissLan™ Digital Pregnancy Rapid Test
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 Received08/01/2022
Decision Date 11/30/2022
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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