FDA 510(k)

ADVIA Centaur IgE Total (tIgE)

Número K: K193493 · 2020-01-15

RequerenteSiemens Healthcare Diagnostics, Inc.

Data da decisão2020-01-15

Código do produtoDGC

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

ADVIA Centaur Total IgE (tIgE) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-01-15 under 510(k) number K193493. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ADVIA Centaur Total IgE (tIgE)?

ADVIA Centaur Total IgE (tIgE) is a medical device that received FDA 510(k) clearance on 2020-01-15. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K193493.

When did ADVIA Centaur Total IgE (tIgE) receive FDA 510(k) clearance?

ADVIA Centaur Total IgE (tIgE) received FDA 510(k) clearance on 2020-01-15, under 510(k) number K193493.

Who is the listed applicant for ADVIA Centaur Total IgE (tIgE)?

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

What is the FDA product code for ADVIA Centaur Total IgE (tIgE)?

The FDA product code for ADVIA Centaur Total IgE (tIgE) is DGC.

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