FDA 510(k)

Elecsys CMV IgG

K-Number: K220911 · 2022-10-12

Decision Date2022-10-12

Product CodeLFZ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Elecsys CMV IgG is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2022-10-12 under approval 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. It is manufactured by Roche Diagnostics. The 510(k) number is K220911.

When was Elecsys CMV IgG approved by the FDA?

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

What company makes Elecsys CMV IgG?

Elecsys CMV IgG is manufactured by Roche Diagnostics.

What is the FDA product code for Elecsys CMV IgG?

The FDA product code for Elecsys CMV IgG is LFZ.

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Related Devices (Code: LFZ)

K163569Elecsys CMV IgMRoche Diagnostics K162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc. K181213ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSiemens Healthcare Diagnostics, Inc. K220949Architect CMV IgGAbbott Laboratories

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.