K243346
- 510(k) number
- K243346
- Device name
- cobas liat SARS-CoV-2 v2 nucleic acid test
- Applicant
- Roche Molecular Systems, Inc. CA · US
- Product code
- QWR — Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucl
- Decision date
- 2025-04-11
- Date received
- 2024-10-28
- 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: K243346.pdf
Official FDA record: K243346
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.