K223783
- 510(k) number
- K223783
- Device name
- cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
- Applicant
- Roche Molecular Systems, Inc. CA · US
- Product code
- QWR — Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucl
- Decision date
- 2023-12-04
- Date received
- 2022-12-16
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K223783.pdf
Official FDA record: K223783
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.