510(k) K221842 · QSE AlzheimerS Disease Pathology Assessment Test
Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 7, 2022 |
| Received | Jun 24, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221842
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.