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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
510(k) Number K251993
Device Name Panther Fusion GI Expanded Bacterial Assay
Applicant
Hologic, Inc.
10210 Genetic Center Dr.
San Diego,  CA  92121
Applicant Contact Patricia Villarreal
Correspondent
Hologic, Inc.
10210 Genetic Center Dr.
San Diego,  CA  92121
Correspondent Contact Patricia Villarreal
Regulation Number866.3990
Classification Product Code
PCH  
Subsequent Product Code
OOI  
Date Received06/27/2025
Decision Date 09/25/2025
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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