510(k) K240867 · QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Feb 11, 2025 |
| Received | Mar 29, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240867
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.