Cleared Traditional

Alegria Flash ENA Screen

K250408 · Zeus Scientific · Immunology
Sep 2025
Decision
218d
Days
Class 2
Risk

About This 510(k) Submission

K250408 is an FDA 510(k) clearance for the Alegria Flash ENA Screen, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Zeus Scientific (Branchburg, US). The FDA issued a Cleared decision on September 19, 2025, 218 days after receiving the submission on February 13, 2025. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K250408 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2025
Decision Date September 19, 2025
Days to Decision 218 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code LLL — Extractable Antinuclear Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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