510(k) K213804 ยท QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Oct 22, 2022 |
| Received | Dec 6, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213804
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.