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FDA 510(k)

LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set

K-Number: K162959 · 2017-01-04

ApplicantDiaSorin, Inc.
Decision Date2017-01-04
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set is a medical device manufactured by DiaSorin, Inc.. It received FDA 510(k) clearance on 2017-01-04 under approval number K162959. The device is classified under product code LSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set?

LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set is a medical device that received FDA 510(k) clearance on 2017-01-04. It is manufactured by DiaSorin, Inc.. The 510(k) number is K162959.

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

LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set received FDA 510(k) clearance on 2017-01-04, under approval number K162959.

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

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

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

The FDA product code for LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set is LSE.

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Related Devices (Code: LSE)

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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.

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