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PMA de la FDA

Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer

Número de PMA: P100024 · 2017-04-12

SolicitanteDako Denmark A/S
Fecha de decisión2017-04-12
Número PMAP100024
Código de productoNYQ
Clase del dispositivoClase 3
Especialidad médicaU
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 Dako Denmark A/S. It received FDA 510(k) clearance on 2017-04-12. 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 2017-04-12. The listed applicant is Dako Denmark A/S.

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 Dako Denmark A/S 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?

El código de producto de la FDA para la hibridación in situ cromogénica, amplificación de ácidos nucleicos, gen HER2/NEU, cáncer de mama es 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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