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FDA 510(k)

LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus

K-Number: K213858 · 2022-07-26

ApplicantDiaSorin, Inc.
Decision Date2022-07-26
Product CodeNXO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus is a medical device manufactured by DiaSorin, Inc.. It received FDA 510(k) clearance on 2022-07-26 under approval number K213858. The device is classified under product code NXO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus?

LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus is a medical device that received FDA 510(k) clearance on 2022-07-26. It is manufactured by DiaSorin, Inc.. The 510(k) number is K213858.

When was LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus approved by the FDA?

LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus received FDA 510(k) clearance on 2022-07-26, under approval number K213858.

What company makes LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus?

LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus is manufactured by DiaSorin, Inc..

What is the FDA product code for LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus?

The FDA product code for LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus is NXO.

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Related Devices (Code: NXO)

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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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