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PMA de la FDA

Somatic gene mutation detection system

Número de PMA: P150047 · 2016-10-19

SolicitanteRoche Molecular Systems, Inc.
Fecha de decisión2016-10-19
Número PMAP150047
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 Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2016-10-19. 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 2016-10-19. The listed applicant is Roche Molecular Systems, Inc..

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 Roche Molecular Systems, Inc. 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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