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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
Predetermined Change
Control Plan Authorized		 No
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