DIASORIN LIAISON CMV IGM/IGG— 510(k) K040290

Substantially Equivalent

Diasorin S.P.A

FDA 510(k) clearance K040290 for DIASORIN LIAISON CMV IGM/IGG, Substantially Equivalent on 2005-06-01. Applicant: Diasorin S.P.A. Device class: 2.

Clearance details

Applicant: Diasorin S.P.A
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 2004-02-06
Decision date: 2005-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFZ

K220949 — Architect CMV IgG2022-10-27
K220911 — Elecsys CMV IgG2022-10-12
K181213 — ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control2018-07-30
K163569 — Elecsys CMV IgM2017-03-17
K162969 — LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set2017-01-06

More clearances from Diasorin S.P.A

K052499 — DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS2006-02-08

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