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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name simple point-of-care device to directly detect sars-cov-2 viral targets from clinical specimens in near-patient settings
510(k) Number K232377
Device Name Healgen Rapid COVID-19 Antigen Test
Healgen Scientific LLC
3818 Fuqua Street
Houston,  TX  77047
Applicant Contact Jinjie Hu
Axteria Biomed Consulting
8040 Cobble Creek Circle
Potomac,  MD  20854
Correspondent Contact Jinjie Hu
Regulation Number866.3982
Classification Product Code
Date Received08/08/2023
Decision Date 04/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No