FDA 510(k)

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

Número K: K213858 · 2022-07-26

Data da decisão2022-07-26

Código do produtoNXO

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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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Fonte oficial

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