K253367
- 510(k) number
- K253367
- Device name
- EliA CTD 13 Screen
- Applicant
- Phadia AB SE
- Product code
- LLL — Extractable Antinuclear Antibody, Antigen And Contro
- Decision date
- 2026-06-25
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K253367.pdf
Official FDA record: K253367
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.