510(k) K243753 ยท OZZ Bordetella Pertussis Dna Assay System
cobas liat Bordetella panel nucleic acid test
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Nov 20, 2025 |
| Received | Dec 5, 2024 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K243753
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.