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FDA PMA

Immunohistochemistry Assay, Antibody

Número do PMA: P250031 · 2026-06-12

RequerenteVentana Medical Systems, Inc. (Roche Tissue Diagnostics)
Data da decisão2026-06-12
Número PMAP250031
Código do produtoSHF
Comité consultivoPA

Resumo do dispositivo

Immunohistochemistry Assay, Antibody is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics). It received FDA 510(k) clearance on 2026-06-12. The device is classified under product code SHF. It was reviewed by the PA advisory panel.

Perguntas frequentes

What is the Immunohistochemistry Assay, Antibody?

Immunohistochemistry Assay, Antibody is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics).

When did Immunohistochemistry Assay, Antibody receive FDA 510(k) clearance?

The clearance date for Immunohistochemistry Assay, Antibody can be found in the official FDA records.

Who is the listed applicant for Immunohistochemistry Assay, Antibody?

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

What is the FDA product code for Immunohistochemistry Assay, Antibody?

The FDA product code for Immunohistochemistry Assay, Antibody is SHF.

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