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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 K212418
Device Name hCG One Step Pregnancy Test
Applicant
Healstone Biotech, Inc.
Unit 650, 655 W. Kent Ave. N.,
Vancouver,  CA V6P 6
Applicant Contact Guang Gao
Correspondent
Axteria Biomed Consulting
8040 Cobble Creek Circle
Potomac,  MD  20854
Correspondent Contact Guang Gao
Regulation Number862.1155
Classification Product Code
LCX  
Date Received08/03/2021
Decision Date 06/30/2022
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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