DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS— 510(k) K052499

Name: FDA 510(k) clearance K052499
Creator: U.S. Food and Drug Administration
Published: 2006-02-08

Substantially Equivalent

Diasorin S.P.A

FDA 510(k) clearance K052499 for DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS, Substantially Equivalent on 2006-02-08. Applicant: Diasorin S.P.A. Device class: 2.

Clearance details

Applicant: Diasorin S.P.A
Product code: Code LGD
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 2005-09-13
Decision date: 2006-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LGD

view all

K242022 — Access Toxo IgG2025-03-28
K242095 — Access Toxo IgM II2024-10-11
K233932 — Alinity i Toxo IgM2024-08-30
K210596 — ARCHITECT Toxo IgG2022-05-19
K162678 — Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl2017-06-23

More clearances from Diasorin S.P.A

view all

K040290 — DIASORIN LIAISON CMV IGM/IGG2005-06-01

Adverse events under product code LGD

product code LGD

Malfunction: 502
Total: 502

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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