K252431
- 510(k) number
- K252431
- Device name
- Elecsys Calcitonin
- Applicant
- Roche Diagnostics GmbH DE
- Product code
- JKR — Radioimmunoassay, Calcitonin
- Decision date
- 2026-04-24
- Date received
- 2025-08-01
- 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: K252431.pdf
Official FDA record: K252431
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.