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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 K253882
Device Name CorDx Tyfast COVID-19 Ag Rapid Test Rx
Applicant
CorDx, Inc.
5900 Windward Pkwy.
Alpharetta,  GA  30005
Applicant Contact Aiiso Ally yang
Correspondent
CorDx, Inc.
5900 Windward Pkwy.
Alpharetta,  GA  30005
Correspondent Contact Aiiso Ally yang
Classification Product Code
QVF  
Date Received12/04/2025
Decision Date 06/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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