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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Respiratory Virus Antigen Detection Test
510(k) Number K262432
Device Name CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test
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
SCA  
Date Received07/16/2026
Decision Date 10/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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