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PMA de la FDA

Panel de oncología de secuenciación de próxima generación, sistema de detección de variantes somáticas o germinales

Número de PMA: P230011 · 2026-09-04

SolicitanteIllumina, Inc.
Fecha de decisión2026-09-04
Número PMAP230011
Código de productoPQP
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorPA

Resumen del dispositivo

Next generation sequencing oncology panel, somatic or germline variant detection system is the device name listed in this FDA 510(k) record. The listed applicant is Illumina, Inc.. It received FDA 510(k) clearance on 2026-09-04. The device is classified under product code PQP. It was reviewed by the PA advisory panel.

Preguntas frecuentes

What is the Next generation sequencing oncology panel, somatic or germline variant detection system?

Next generation sequencing oncology panel, somatic or germline variant detection system is a medical device that received FDA 510(k) clearance on 2026-09-04. The listed applicant is Illumina, Inc..

When did Next generation sequencing oncology panel, somatic or germline variant detection system receive FDA 510(k) clearance?

The clearance date for Next generation sequencing oncology panel, somatic or germline variant detection system can be found in the official FDA records.

Who is the listed applicant for Next generation sequencing oncology panel, somatic or germline variant detection system?

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

What is the FDA product code for Next generation sequencing oncology panel, somatic or germline variant detection system?

The FDA product code for Next generation sequencing oncology panel, somatic or germline variant detection system is PQP.

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Fuente oficial

Ver en la base de datos de la FDA →

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