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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 K240643
Device Name MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy 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, Inc.
504 E Diamond Ave.
Suite H
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.1155
Classification Product Code
LCX  
Date Received03/07/2024
Decision Date 06/21/2024
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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