FDA 510(k)

LIAISON VZV IgG HT, LIAISON Control VZV IgG HT

Número K: K231214 · 2023-10-27

Data da decisão2023-10-27

Código do produtoLFY

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

LIAISON VZV IgG HT, LIAISON Control VZV IgG HT is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K231214. The device is classified under product code LFY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LIAISON VZV IgG HT, LIAISON Control VZV IgG HT?

LIAISON VZV IgG HT, LIAISON Control VZV IgG HT is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is DiaSorin, Inc.. The 510(k) number is K231214.

When did LIAISON VZV IgG HT, LIAISON Control VZV IgG HT receive FDA 510(k) clearance?

LIAISON VZV IgG HT, LIAISON Control VZV IgG HT received FDA 510(k) clearance on 2023-10-27, under 510(k) number K231214.

Who is the listed applicant for LIAISON VZV IgG HT, LIAISON Control VZV IgG HT?

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 VZV IgG HT, LIAISON Control VZV IgG HT?

The FDA product code for LIAISON VZV IgG HT, LIAISON Control VZV IgG HT is LFY.

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Fonte oficial

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