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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 K220963
Device Name Simplexa COVID-19 & Flu A/B Direct
Applicant
DiaSorin Molecular LLC
11331 Valley View Street
Cypress,  CA  90630
Applicant Contact Sharon Young
Correspondent
DiaSorin Molecular LLC
11331 Valley View Street
Cypress,  CA  90630
Correspondent Contact Tara Viviani
Regulation Number866.3981
Classification Product Code
QOF  
Subsequent Product Code
OOI  
Date Received04/01/2022
Decision Date 03/17/2023
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
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