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FDA PMA

Immunohistochemistry assay, antibody, anaplastic lymphoma kinase

Número do PMA: P140025 · 2025-06-20

RequerenteVentana Medical Systems, Inc.
Data da decisão2025-06-20
Número PMAP140025
Código do produtoPKW
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoPA

Resumo do dispositivo

Immunohistochemistry assay, antibody, anaplastic lymphoma kinase is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc.. It received FDA 510(k) clearance on 2025-06-20. The device is classified under product code PKW. It was reviewed by the PA advisory panel.

Perguntas frequentes

What is the Immunohistochemistry assay, antibody, anaplastic lymphoma kinase?

Immunohistochemistry assay, antibody, anaplastic lymphoma kinase is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Ventana Medical Systems, Inc..

When did Immunohistochemistry assay, antibody, anaplastic lymphoma kinase receive FDA 510(k) clearance?

The clearance date for Immunohistochemistry assay, antibody, anaplastic lymphoma kinase can be found in the official FDA records.

Who is the listed applicant for Immunohistochemistry assay, antibody, anaplastic lymphoma kinase?

The FDA 510(k) record lists Ventana Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Immunohistochemistry assay, antibody, anaplastic lymphoma kinase?

The FDA product code for Immunohistochemistry assay, antibody, anaplastic lymphoma kinase is PKW.

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Fonte oficial

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