510(k) K231348 · QSE AlzheimerS Disease Pathology Assessment Test
Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 5, 2023 |
| Received | May 9, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231348
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.