FDA 510(k)

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

K-Number: K213858 · 2022-07-26

Decision Date2022-07-26

Product CodeNXO

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2022-07-26 under 510(k) 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. The listed applicant is DiaSorin, Inc.. The 510(k) number is K213858.

When did LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus receive FDA 510(k) clearance?

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

Who is the listed applicant for LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus?

The FDA 510(k) record lists DiaSorin, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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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.