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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 K251092
Device Name iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro
Applicant
Ihealth Labs, Inc.
880 W Maude Ave.
Sunnyvale,  CA  94085
Applicant Contact Yange Wang
Correspondent
Ihealth Labs, Inc.
880 W Maude Ave.
Sunnyvale,  CA  94085
Correspondent Contact Yange Wang
Classification Product Code
SCA  
Date Received04/10/2025
Decision Date 12/12/2025
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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