Lumipulse G ß-Amyloid Ratio (1-42/1-40)
FDA 510(k) clearance DEN200072 · decided 2022-05-04
Clearance details
- K-number
- DEN200072
- Device name
- Lumipulse G ß-Amyloid Ratio (1-42/1-40)
- Applicant
- Fujirebio Diagnostics,Inc.
- Decision
- Unknown
- Date received
- 2020-11-20
- Decision date
- 2022-05-04
- Days to decision
- 530 days
- Clearance type
- Direct
- Product code
- QSE
- Device class
- 2
- Regulation number
- 866.5840
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF (K231348) | Roche Diagnostics | 2023-06-05 |
| Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF (K221842) | Roche Diagnostics | 2022-12-07 |
Recalls involving this device
No recalls on record reference this clearance.