FDA Product Code
FDA Product Code SET — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5840
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) Plasma | Roche Diagnostics | 2026-08-19 | Traditional | PDF ↗ |
| K253240 | PrecivityAD2 Test | C2N Diagnostics, LLC | 2026-08-19 | Traditional | PDF ↗ |
| K252163 | Elecsys Phospho-Tau (181P) Plasma | Roche Diagnostics | 2025-10-08 | Traditional | PDF ↗ |
| K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | Fujirebio Diagnostics,Inc. | 2025-05-16 | Traditional | PDF ↗ |
Product code SET · Class II · Immunology. Data: openFDA.