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FDA 510(k)

LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set

K-Number: K161139 · 2016-07-22

ApplicantDiaSorin, Inc.
Decision Date2016-07-22
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set is a medical device manufactured by DiaSorin, Inc.. It received FDA 510(k) clearance on 2016-07-22 under approval number K161139. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set?

LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set is a medical device that received FDA 510(k) clearance on 2016-07-22. It is manufactured by DiaSorin, Inc.. The 510(k) number is K161139.

When was LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set approved by the FDA?

LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set received FDA 510(k) clearance on 2016-07-22, under approval number K161139.

What company makes LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set?

LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set is manufactured by DiaSorin, Inc..

What is the FDA product code for LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set?

The FDA product code for LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set is LYR.

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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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