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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 K231017
Device Name Panther Fusion AdV/hMPV/RV Assay
Applicant
Hologic, Inc.
10210 Genetic Center Dr
SAN DIEGO,  CA  92121
Applicant Contact Jon Kukowski
Correspondent
Hologic, Inc.
10210 Genetic Center Dr
SAN DIEGO,  CA  92121
Correspondent Contact Jon Kukowski
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
OEM   OOI  
Date Received04/10/2023
Decision Date 05/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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