Panels › Immunology › Product code SET · Class 2
Immunoassay Blood Test For Amyloid Pathology Assessment
Regulation 866.5840
2510(k)s in 12 months (4 all time)
7recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in SET
| Company | 510(k)s | Recalls |
|---|---|---|
| Fujirebio Diagnostics,Inc. | 1 | 7 |
| Roche Diagnostics | 2 | 0 |
| C2N Diagnostics, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 19, 2026 | K261686 | Elecsys Phospho-Tau (217P) Plasma Roche Diagnostics | SET |
| Aug 19, 2026 | K253240 | PrecivityAD2 Test C2N Diagnostics, LLC | SET |
| Oct 8, 2025 | K252163 | Elecsys Phospho-Tau (181P) Plasma Roche Diagnostics | SET |
| May 16, 2025 | K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio Fujirebio Diagnostics,Inc. | SET |
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