Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB— 510(k) K250814

Name: FDA 510(k) clearance K250814
Creator: U.S. Food and Drug Administration
Published: 2026-05-08

Substantially Equivalent

Zeus Scientific

FDA 510(k) clearance K250814 for Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB, Substantially Equivalent on 2026-05-08. Applicant: Zeus Scientific. Device class: 2.

Clearance details

Applicant: Zeus Scientific
Product code: Code OBE
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2025-03-17
Decision date: 2026-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OBE

view all

K141655 — QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS2015-03-05
K063565 — QUANTA LITE SS-A 52 ELISA2007-04-04

More clearances from Zeus Scientific

view all

K261466 — Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM2026-08-21
K250666 — Alegria Flash CTD Screen2025-10-22
K250408 — Alegria Flash ENA Screen2025-09-19
K243776 — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)2025-05-07
K231616 — ZEUS IFA(TM) nDNA Test System, ZEUS dIFine2023-08-31

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