Source document or public record
FDA 510(k) K262893 — Eonis SMA kit
FDA 510(k) index record K262893. Device: Eonis SMA kit. Applicant as listed: Revvity, Inc.. Decision date: 2026-09-30.
Source
"device_name": "Eonis SMA kit"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K262893.
Device name: Eonis SMA kit. Applicant as listed: Revvity, Inc..
Decision date: 2026-09-30. Decision wording: Substantially Equivalent.
Product code: QUE. Regulation: 21 CFR 866.5980. 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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