510(k) K252163
- Device
- Elecsys Phospho-Tau (181P) Plasma
- Applicant
- Roche Diagnostics
- 510(k) number
- K252163
- Product code
- SET
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-08
- Date received
- 2025-07-10
- Regulation
- 866.5840
- Classification name
- Immunoassay Blood Test For Amyloid Pathology Assessment
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Stephan Knierer
- Address
- 9115 Hague Rd. P.O. Box 50416 Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 2521625
- 9610126
- 9615837
- 3002895169
Source Documents#
Other 510(k) Records For Product Code SET#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | Fujirebio Diagnostics,Inc. | 2025-05-16 |