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PMA de la FDA

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

Número de PMA: P190031 · 2026-08-25

SolicitanteVentana Medical Systems, Inc.
Fecha de decisión2026-08-25
Número PMAP190031
Código de productoNYQ
Clase del dispositivoClase 2
Especialidad médicaP
Número de regulación21 CFR 8
Comité asesorPA

Resumen del dispositivo

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer 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 2026-08-25. The device is classified under product code NYQ. It was reviewed by the PA advisory panel.

Preguntas frecuentes

What is the Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer?

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer is a medical device that received FDA 510(k) clearance on 2026-08-25. The listed applicant is Ventana Medical Systems, Inc..

When did Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer receive FDA 510(k) clearance?

The clearance date for Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer can be found in the official FDA records.

Who is the listed applicant for Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer?

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 Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer?

The FDA product code for Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer is NYQ.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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