510(k) K243455 ยท QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Jul 31, 2025 |
| Received | Nov 7, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243455
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.