Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM— 510(k) K261466

Name: FDA 510(k) clearance K261466
Creator: U.S. Food and Drug Administration
Published: 2026-08-21

Substantially Equivalent

Zeus Scientific

FDA 510(k) clearance K261466 for Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM, Substantially Equivalent on 2026-08-21. Applicant: Zeus Scientific. Device class: 2.

Clearance details

Applicant: Zeus Scientific
Product code: Code MOB
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2026-05-04
Decision date: 2026-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

Download summary PDF View on FDA.gov ↗

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K173792 — EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay2018-03-13
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More clearances from Zeus Scientific

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K250814 — Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB2026-05-08
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K250408 — Alegria Flash ENA Screen2025-09-19
K231616 — ZEUS IFA(TM) nDNA Test System, ZEUS dIFine2023-08-31
K230863 — ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit2023-07-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.