Source document or public record
FDA 510(k) K250814 — Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB
FDA 510(k) index record K250814. Device: Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB. Applicant as listed: Zeus Scientific. Decision date: 2026-05-08.
Source
"device_name": "Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB"
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 K250814.
Device name: Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB. Applicant as listed: Zeus Scientific.
Decision date: 2026-05-08. Decision wording: Substantially Equivalent.
Product code: OBE. 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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