FDA Product Code
FDA Product Code QSE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5840
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231348 | Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF | Roche Diagnostics | 2023-06-05 | Traditional | PDF ↗ |
| K221842 | Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF | Roche Diagnostics | 2022-12-07 | Traditional | PDF ↗ |
| DEN200072 | Lumipulse G ß-Amyloid Ratio (1-42/1-40) | Fujirebio Diagnostics,Inc. | 2022-05-04 | Direct | — |
Product code QSE · Class II · Immunology. Data: openFDA.