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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 K233842
Device Name iHealth COVID-19 Antigen Rapid Test
Applicant
iHealth Labs, Inc
880 W Maude Ave
Sunnyvale,  CA  94085
Applicant Contact Tianyang Liu
Correspondent
iHealth Labs, Inc
880 W Maude Ave
Sunnyvale,  CA  94085
Correspondent Contact Tianyang Liu
Classification Product Code
QYT  
Date Received12/04/2023
Decision Date 05/31/2024
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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