510(k) K243346 ยท QWR Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
cobas liat SARS-CoV-2 v2 nucleic acid test
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Apr 11, 2025 |
| Received | Oct 28, 2024 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K243346
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.