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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 K222736
Device Name Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
Applicant
Hologic, Inc.
10210 Genetic Center Drive
San Diego,  CA  92121
Applicant Contact Vlada Rudenko
Correspondent
Hologic, Inc.
10210 Genetic Center Drive
San Diego,  CA  92121
Correspondent Contact Vlada Rudenko
Regulation Number866.3981
Classification Product Code
QOF  
Date Received09/09/2022
Decision Date 05/16/2023
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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