Lumipulse G ß-Amyloid Ratio (1-42/1-40)— 510(k) DEN200072

Name: FDA 510(k) clearance DEN200072
Creator: U.S. Food and Drug Administration
Published: 2022-05-04

Unknown

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance DEN200072 for Lumipulse G ß-Amyloid Ratio (1-42/1-40), Unknown on 2022-05-04. Applicant: Fujirebio Diagnostics,Inc.. Device class: 2.

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code QSE
Device class: Class 2
Regulation: 21 CFR 866.5840
Advisory panel: Immunology
Date received: 2020-11-20
Decision date: 2022-05-04
Decision: Unknown
Clearance type: Direct
Location: Malvern, PA, US

View on FDA.gov ↗

Recent devices under product code QSE

view all

K231348 — Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF2023-06-05
K221842 — Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF2022-12-07

More clearances from Fujirebio Diagnostics,Inc.

view all

K250925 — ADVIA Centaur Cytokeratin Fragment 21-12025-12-16
K242706 — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio2025-05-16
K192524 — Lumipulse G CA15-32020-09-04
K192380 — ST AIA-PACK BNP2020-08-24
K200997 — Lumipulse G CA19-9-N2020-05-14

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