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FDA 510(k)

Elecsys CMV IgG

K-Number: K220911 · 2022-10-12

ApplicantRoche Diagnostics
Decision Date2022-10-12
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Elecsys CMV IgG is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2022-10-12 under 510(k) number K220911. 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 Elecsys CMV IgG?

Elecsys CMV IgG is a medical device that received FDA 510(k) clearance on 2022-10-12. The listed applicant is Roche Diagnostics. The 510(k) number is K220911.

When did Elecsys CMV IgG receive FDA 510(k) clearance?

Elecsys CMV IgG received FDA 510(k) clearance on 2022-10-12, under 510(k) number K220911.

Who is the listed applicant for Elecsys CMV IgG?

The FDA 510(k) record lists Roche Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elecsys CMV IgG?

The FDA product code for Elecsys CMV IgG is LFZ.

Other records listing Roche Diagnostics as applicant

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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 LaboratoriesK181213ADVIA 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.

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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