Documento fuente o registro público

FDA 510(k) K253367 — EliA CTD 13 Screen

FDA 510(k) index record K253367. Device: EliA CTD 13 Screen. Applicant as listed: Phadia AB. Decision date: 2026-06-25.

OtherU.S. Food and Drug Administration (FDA)2026-06-25

Fuente

"device_name": "EliA CTD 13 Screen"
api.fda.gov · Consultado el 2026-10-21

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-22

Disclaimer

professional use

References

FDA 510(k) public index record K253367.

Device name: EliA CTD 13 Screen. Applicant as listed: Phadia AB.

Decision date: 2026-06-25. Decision wording: Substantially Equivalent.

Product code: LLL. Regulation: 21 CFR 866.5100. Medical specialty: Immunology.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

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FDA 510(k) K253367 — EliA CTD 13 Screen

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