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PMA de la FDA

SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM

Número de PMA: P040005 · 2017-04-12

SolicitanteAgilent Technologies Singapore (International) Pte , Ltd.
Fecha de decisión2017-04-12
Número PMAP040005
Código de productoMVD
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorPA

Resumen del dispositivo

SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Agilent Technologies Singapore (International) Pte , Ltd.. It received FDA 510(k) clearance on 2017-04-12. The device is classified under product code MVD. It was reviewed by the PA advisory panel.

Preguntas frecuentes

What is the SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM?

SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM is a medical device that received FDA 510(k) clearance on 2017-04-12. The listed applicant is Agilent Technologies Singapore (International) Pte , Ltd..

When did SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM receive FDA 510(k) clearance?

The clearance date for SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM can be found in the official FDA records.

Who is the listed applicant for SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM?

The FDA 510(k) record lists Agilent Technologies Singapore (International) Pte , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM?

The FDA product code for SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM is MVD.

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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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