Source document or public record
FDA 510(k) K261466 — Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM
FDA 510(k) index record K261466. Device: Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM. Applicant as listed: Zeus Scientific. Decision date: 2026-08-21.
Source
"device_name": "Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM"
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 K261466.
Device name: Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM. Applicant as listed: Zeus Scientific.
Decision date: 2026-08-21. Decision wording: Substantially Equivalent.
Product code: MOB. Regulation: 21 CFR 866.5660. 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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