510(k) K260021 · PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
cobas® BV/CV
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Jul 16, 2026 |
| Received | Jan 5, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260021
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.