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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Influenza A And Influenza B Multiplex Nucleic Acid Assay
510(k) Number K230236
Device Name Lyra Influenza A+B Assay
Applicant
Quidel Corporation
10165 McKellar Court
San Diego,  CA  92121
Applicant Contact Selena Liu
Correspondent
Quidel Corporation
10165 McKellar Court
San Diego,  CA  92121
Correspondent Contact Selena Liu
Regulation Number866.3980
Classification Product Code
OZE  
Subsequent Product Code
OOI  
Date Received01/30/2023
Decision Date 03/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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