FDA 510(k)

LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set

K-Number: K162969 · 2017-01-06

Decision Date2017-01-06

Product CodeLFZ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set is a medical device manufactured by DiaSorin, Inc.. It received FDA 510(k) clearance on 2017-01-06 under approval number K162969. 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 LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set?

LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set is a medical device that received FDA 510(k) clearance on 2017-01-06. It is manufactured by DiaSorin, Inc.. The 510(k) number is K162969.

When was LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set approved by the FDA?

LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set received FDA 510(k) clearance on 2017-01-06, under approval number K162969.

What company makes LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set?

LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set is manufactured by DiaSorin, Inc..

What is the FDA product code for LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set?

The FDA product code for LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set is LFZ.

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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.