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FDA 510(k)

ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control

K-Number: K181213 · 2018-07-30

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2018-07-30
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-07-30 under approval number K181213. 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 ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control?

ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control is a medical device that received FDA 510(k) clearance on 2018-07-30. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K181213.

When was ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control approved by the FDA?

ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control received FDA 510(k) clearance on 2018-07-30, under approval number K181213.

What company makes ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control?

ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control?

The FDA product code for ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control 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. 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.

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