EliA CTD 13 Screen— 510(k) K253367
Substantially EquivalentPhadia AB
FDA 510(k) clearance K253367 for EliA CTD 13 Screen, Substantially Equivalent on 2026-06-25. Applicant: Phadia AB. Device class: 2.
Summary
Phadia's EliA CTD 13 Screen is filed under LLL, extractable antinuclear antibody antigens and controls. The record doesn't expand "CTD" or say what the 13 refers to.
Class II, 21 CFR 866.5100. Immunology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Phadia filed from Uppsala, Sweden. The decision came 268 calendar days after FDA received it (September 30, 2025 to June 25, 2026).
Clearance details
- Applicant
- Phadia AB
- Product code
- Product code LLL
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Uppsala, SE
Recent devices under product code LLL
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Data sourced from openFDA. This site is unofficial and independent of the FDA.