510(k) DEN200072 · QSE AlzheimerS Disease Pathology Assessment Test
Lumipulse G ß-Amyloid Ratio (1-42/1-40)
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Unknown, May 4, 2022 |
| Received | Nov 20, 2020 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN200072
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.