K243406
- 510(k) number
- K243406
- Device name
- cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
- Applicant
- Roche Molecular Systems, Inc. CA · US
- Product code
- QOF — Multi-Target Respiratory Specimen Nucleic Acid Test
- Decision date
- 2025-04-25
- Date received
- 2024-11-01
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243406.pdf
Official FDA record: K243406
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.