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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 K242465
Device Name Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
Applicant
Hologic, Inc.
10210 Genetic Center Dr.
San Diego,  CA  92121
Applicant Contact Vlada Rudenko
Correspondent
Hologic, Inc.
10210 Genetic Center Dr.
San Diego,  CA  92121
Correspondent Contact Vlada Rudenko
Regulation Number866.3981
Classification Product Code
QOF  
Subsequent Product Code
OOI  
Date Received08/20/2024
Decision Date 11/15/2024
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
Predetermined Change
Control Plan Authorized		 No
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