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PMA de la FDA

Somatic gene mutation detection system

Número de PMA: P120022 · 2021-07-07

SolicitanteQIAGEN GmbH
Fecha de decisión2021-07-07
Número PMAP120022
Código de productoOWD
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorPA

Resumen del dispositivo

Somatic gene mutation detection system is the device name listed in this FDA 510(k) record. The listed applicant is QIAGEN GmbH. It received FDA 510(k) clearance on 2021-07-07. The device is classified under product code OWD. It was reviewed by the PA advisory panel.

Preguntas frecuentes

What is the Somatic gene mutation detection system?

Somatic gene mutation detection system is a medical device that received FDA 510(k) clearance on 2021-07-07. The listed applicant is QIAGEN GmbH.

When did Somatic gene mutation detection system receive FDA 510(k) clearance?

The clearance date for Somatic gene mutation detection system can be found in the official FDA records.

Who is the listed applicant for Somatic gene mutation detection system?

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

What is the FDA product code for Somatic gene mutation detection system?

The FDA product code for Somatic gene mutation detection system is OWD.

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Fuente oficial

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