K242706
- 510(k) number
- K242706
- Device name
- Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
- Applicant
- Fujirebio Diagnostics,Inc. PA · US
- Product code
- SET — Immunoassay Blood Test For Amyloid Pathology Assessm
- Decision date
- 2025-05-16
- Date received
- 2024-09-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K242706.pdf
Official FDA record: K242706
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.