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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over-The-Counter Covid-19 Antigen Test
510(k) Number K240728
Device Name CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test
Applicant
CorDx, Inc.
9540 Waples St. # C
San Diego,  CA  92121
Applicant Contact Haixia Yang
Correspondent
Axteria Biomed Consulting Inc.
8040 Cobble Creek Circle
Potomac,  MD  20854
Correspondent Contact Jinjie Hu
Classification Product Code
QYT  
Date Received03/18/2024
Decision Date 06/21/2024
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
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