FDA 510(k)

ADVIA Centaur Hormônio Paratiroide Inteiro (PTH) Ensaio

Número K: K163658 · 2017-05-23

RequerenteSiemens Healthcare Diagnostics, Inc.

Data da decisão2017-05-23

Código do produtoCEW

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay 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 2017-05-23 under 510(k) number K163658. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay?

ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay is a medical device that received FDA 510(k) clearance on 2017-05-23. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K163658.

When did ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay receive FDA 510(k) clearance?

ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay received FDA 510(k) clearance on 2017-05-23, under 510(k) number K163658.

Who is the listed applicant for ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay?

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 Intact Parathyroid Hormone (PTH) Assay?

The FDA product code for ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay is CEW.

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Fonte oficial

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