FDA 510(k)

ADVIA Centaur Anti-Peroxidase de Tiroide II

Número K: K250250 · 2025-10-17

RequerenteSiemens Healthcare Diagnostics, Inc.

Data da decisão2025-10-17

Código do produtoJZO

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

ADVIA Centaur Anti-Thyroid Peroxidase II 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 2025-10-17 under 510(k) number K250250. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ADVIA Centaur Anti-Thyroid Peroxidase II?

ADVIA Centaur Anti-Thyroid Peroxidase II is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K250250.

When did ADVIA Centaur Anti-Thyroid Peroxidase II receive FDA 510(k) clearance?

ADVIA Centaur Anti-Thyroid Peroxidase II received FDA 510(k) clearance on 2025-10-17, under 510(k) number K250250.

Who is the listed applicant for ADVIA Centaur Anti-Thyroid Peroxidase II?

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 Anti-Thyroid Peroxidase II?

The FDA product code for ADVIA Centaur Anti-Thyroid Peroxidase II is JZO.

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