FDA 510(k)

Elecsys CMV IgM

K-Number: K163569 · 2017-03-17

Decision Date2017-03-17

Product CodeLFZ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Elecsys CMV IgM is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2017-03-17 under approval number K163569. 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 IgM?

Elecsys CMV IgM is a medical device that received FDA 510(k) clearance on 2017-03-17. It is manufactured by Roche Diagnostics. The 510(k) number is K163569.

When was Elecsys CMV IgM approved by the FDA?

Elecsys CMV IgM received FDA 510(k) clearance on 2017-03-17, under approval number K163569.

What company makes Elecsys CMV IgM?

Elecsys CMV IgM is manufactured by Roche Diagnostics.

What is the FDA product code for Elecsys CMV IgM?

The FDA product code for Elecsys CMV IgM is LFZ.

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Related Devices (Code: LFZ)

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 K220911Elecsys CMV IgGRoche Diagnostics

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.