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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
510(k) Number K251978
Device Name LIAISON NES FLU A/B, RSV & COVID-19
Applicant
Diasorin Molecular, LLC
11331 Valley View St.
Cypress,  CA  90630
Applicant Contact Sarah Baumann
Correspondent
Diasorin Molecular, LLC
11331 Valley View St.
Cypress,  CA  90630
Correspondent Contact Sarah Baumann
Regulation Number866.3981
Classification Product Code
QOF  
Subsequent Product Code
OOI  
Date Received06/27/2025
Decision Date 12/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
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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