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PMA de la FDA

Immunohistochemistry assay, antibody, claudin 18

Número de PMA: P230018 · 2025-06-20

SolicitanteVentana Medical Systems, Inc.
Fecha de decisión2025-06-20
Número PMAP230018
Código de productoQZJ
Clase del dispositivoClase 3
Especialidad médicaH
Número de regulación21 CFR 8
Comité asesorPA

Resumen del dispositivo

Immunohistochemistry assay, antibody, claudin 18 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 QZJ. It was reviewed by the PA advisory panel.

Preguntas frecuentes

What is the Immunohistochemistry assay, antibody, claudin 18?

Immunohistochemistry assay, antibody, claudin 18 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, claudin 18 receive FDA 510(k) clearance?

The clearance date for Immunohistochemistry assay, antibody, claudin 18 can be found in the official FDA records.

Who is the listed applicant for Immunohistochemistry assay, antibody, claudin 18?

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, claudin 18?

The FDA product code for Immunohistochemistry assay, antibody, claudin 18 is QZJ.

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Fuente oficial

Ver en la base de datos de la FDA →

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