510(k) K243400 ยท QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Apr 25, 2025 |
| Received | Oct 31, 2024 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K243400
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.