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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 K230741
Device Name Macro & Micro-Test HCG Pregnancy Test Midstream
Applicant
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
#888, Zhujiang Rd., Juegang St., Rudong County (Life
& Health Of Rudong High-Tech Zone) Nantong City, Jiangsu
Nantong,  CN 226499
Applicant Contact Bella Xu
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Sandra Jiang
Regulation Number862.1155
Classification Product Code
LCX  
Date Received03/17/2023
Decision Date 10/13/2023
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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