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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name respiratory specimen nucleic acid sars-cov-2 test
510(k) Number K212147
Device Name Simplexa COVID-19 Direct
Applicant
DiaSorin Molecular LLC
11331 Valley View Street
Cypress,  CA  90630
Applicant Contact Tara Viviani
Correspondent
DiaSorin Molecular LLC
11331 Valley View Street
Cypress,  CA  90630
Correspondent Contact Tara Viviani
Regulation Number866.3981
Classification Product Code
QQX  
Date Received07/09/2021
Decision Date 09/13/2022
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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