Panels › Immunology › Product code QSE · Class 2
AlzheimerS Disease Pathology Assessment Test
Regulation 866.5840
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QSE
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Diagnostics | 2 | 0 |
| Fujirebio Diagnostics,Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 5, 2023 | K231348 | Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF Roche Diagnostics | QSE |
| Dec 7, 2022 | K221842 | Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF Roche Diagnostics | QSE |
| May 4, 2022 | DEN200072 | Lumipulse G ß-Amyloid Ratio (1-42/1-40) Fujirebio Diagnostics,Inc. | QSE |
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