K252163
- 510(k) number
- K252163
- Device name
- Elecsys Phospho-Tau (181P) Plasma
- Applicant
- Roche Diagnostics IN · US
- Product code
- SET — Immunoassay Blood Test For Amyloid Pathology Assessm
- Decision date
- 2025-10-08
- Date received
- 2025-07-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252163.pdf
Official FDA record: K252163
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.