FDA 510(k)

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

Número K: K161139 · 2016-07-22

Data da decisão2016-07-22

Código do produtoLYR

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is DiaSorin, Inc.. The 510(k) number is K161139.

When did LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set receive FDA 510(k) clearance?

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

Who is the listed applicant for LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set?

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 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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Fonte oficial

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