Source document or public record

FDA 510(k) K202541 — EliA RNA Pol III

FDA 510(k) index record K202541. Device: EliA RNA Pol III. Applicant as listed: Phadia AB. Decision date: 2021-09-13.

OtherU.S. Food and Drug Administration (FDA)2021-09-13

Source

"device_name": "EliA RNA Pol III"

This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-20

Disclaimer

professional use

FDA 510(k) public index record K202541.

Device name: EliA RNA Pol III. Applicant as listed: Phadia AB.

Decision date: 2021-09-13. Decision wording: Substantially Equivalent.

Product code: NYO. 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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