K241453
- 510(k) number
- K241453
- Device name
- Elecsys sFlt-1 and Elecsys PlGF
- Applicant
- Roche Diagnostics IN · US
- Product code
- QWH — Prognostic Test For Development Or Progression Of Pr
- Decision date
- 2025-02-07
- Date received
- 2024-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K241453.pdf
Official FDA record: K241453
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.