K242465
- 510(k) number
- K242465
- Device name
- Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
- Applicant
- Hologic, Inc. CA · US
- Product code
- QOF — Multi-Target Respiratory Specimen Nucleic Acid Test
- Decision date
- 2024-11-15
- Date received
- 2024-08-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242465.pdf
Official FDA record: K242465
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.