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PMA de la FDA

Assay, enzyme linked immunosorbent, hepatitis c virus

Número de PMA: P190011 · 2021-08-10

SolicitanteDiaSorin, Inc.
Fecha de decisión2021-08-10
Número PMAP190011
Código de productoMZO
Clase del dispositivoClase 2
Especialidad médicaM
Número de regulación21 CFR 8
Comité asesorMI

Resumen del dispositivo

Assay, enzyme linked immunosorbent, hepatitis c virus is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2021-08-10. The device is classified under product code MZO. It was reviewed by the MI advisory panel.

Preguntas frecuentes

What is the Assay, enzyme linked immunosorbent, hepatitis c virus?

Assay, enzyme linked immunosorbent, hepatitis c virus is a medical device that received FDA 510(k) clearance on 2021-08-10. The listed applicant is DiaSorin, Inc..

When did Assay, enzyme linked immunosorbent, hepatitis c virus receive FDA 510(k) clearance?

The clearance date for Assay, enzyme linked immunosorbent, hepatitis c virus can be found in the official FDA records.

Who is the listed applicant for Assay, enzyme linked immunosorbent, hepatitis c virus?

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

What is the FDA product code for Assay, enzyme linked immunosorbent, hepatitis c virus?

The FDA product code for Assay, enzyme linked immunosorbent, hepatitis c virus is MZO.

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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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