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FDA 510(k)

DIASORIN LIAISON CMV IGM/IGG

K-Number: K040290 · 2005-06-01

ApplicantDiasorin S.P.A
Decision Date2005-06-01
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIASORIN LIAISON CMV IGM/IGG is the device name listed in this FDA 510(k) record. The listed applicant is Diasorin S.P.A. It received FDA 510(k) clearance on 2005-06-01 under 510(k) number K040290. The device is classified under product code LFZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIASORIN LIAISON CMV IGM/IGG?

DIASORIN LIAISON CMV IGM/IGG is a medical device that received FDA 510(k) clearance on 2005-06-01. The listed applicant is Diasorin S.P.A. The 510(k) number is K040290.

When did DIASORIN LIAISON CMV IGM/IGG receive FDA 510(k) clearance?

DIASORIN LIAISON CMV IGM/IGG received FDA 510(k) clearance on 2005-06-01, under 510(k) number K040290.

Who is the listed applicant for DIASORIN LIAISON CMV IGM/IGG?

The FDA 510(k) record lists Diasorin S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIASORIN LIAISON CMV IGM/IGG?

The FDA product code for DIASORIN LIAISON CMV IGM/IGG is LFZ.

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Other records listing Diasorin S.P.A as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K052499DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS

Related Devices (Code: LFZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220949Architect CMV IgGAbbott LaboratoriesK220911Elecsys CMV IgGRoche DiagnosticsK181213ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSiemens Healthcare Diagnostics, Inc.K163569Elecsys CMV IgMRoche DiagnosticsK162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc.K993952IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6Diagnostic Products Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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