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FDA 510(k)

Elecsys CMV IgM

K-Number: K163569 · 2017-03-17

ApplicantRoche Diagnostics
Decision Date2017-03-17
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Elecsys CMV IgM is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2017-03-17 under 510(k) 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. The listed applicant is Roche Diagnostics. The 510(k) number is K163569.

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

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

Who is the listed applicant for Elecsys CMV IgM?

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 IgM?

The FDA product code for Elecsys CMV IgM 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 LaboratoriesK220911Elecsys CMV IgGRoche DiagnosticsK181213ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSiemens Healthcare Diagnostics, Inc.K162969LIAISON® 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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