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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name respiratory virus panel nucleic acid assay system
510(k) Number K201505
Device Name Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack
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 Sharon Young
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Code
OOI  
Date Received06/05/2020
Decision Date 08/22/2020
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
Recalls CDRH Recalls
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