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PMA de la FDA

Immunohistochemistry antibody assay, c-kit

Número de PMA: P040011 · 2017-05-16

SolicitanteDako North America, Inc.
Fecha de decisión2017-05-16
Número PMAP040011
Código de productoNKF
Clase del dispositivoClase 3
Especialidad médicaH
Número de regulación21 CFR 8
Comité asesorPA

Resumen del dispositivo

Immunohistochemistry antibody assay, c-kit is the device name listed in this FDA 510(k) record. The listed applicant is Dako North America, Inc.. It received FDA 510(k) clearance on 2017-05-16. The device is classified under product code NKF. It was reviewed by the PA advisory panel.

Preguntas frecuentes

What is the Immunohistochemistry antibody assay, c-kit?

Immunohistochemistry antibody assay, c-kit is a medical device that received FDA 510(k) clearance on 2017-05-16. The listed applicant is Dako North America, Inc..

When did Immunohistochemistry antibody assay, c-kit receive FDA 510(k) clearance?

The clearance date for Immunohistochemistry antibody assay, c-kit can be found in the official FDA records.

Who is the listed applicant for Immunohistochemistry antibody assay, c-kit?

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

What is the FDA product code for Immunohistochemistry antibody assay, c-kit?

The FDA product code for Immunohistochemistry antibody assay, c-kit is NKF.

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Fuente oficial

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