K251993
- 510(k) number
- K251993
- Device name
- Panther Fusion GI Expanded Bacterial Assay
- Applicant
- Hologic, Inc. CA · US
- Product code
- PCH — Gastrointestinal Pathogen Panel Multiplex Nucleic Ac
- Decision date
- 2025-09-25
- Date received
- 2025-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 3.4 MB · U.S. public domain
Also available from FDA: K251993.pdf
Official FDA record: K251993
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.