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FDA 510(k)

Política: regulación medical-vi. Dis El dispositivo_name ADVIA Centaur Anti-CCP IgG (aCCP) assay,., incluyendo reactivos,., calibradores y materiales de controla calidad y curebras.

N.º K: K153551 · 2016-08-04

SolicitanteAxis-Shield Diagnostics Limited
Fecha de decisión2016-08-04
Código de productoNHX
Comité asesorIM
DecisiónSubstantially Equivalent

Resumen del dispositivo

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics Limited. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K153551. The device is classified under product code NHX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.?

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Axis-Shield Diagnostics Limited. The 510(k) number is K153551.

When did ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. receive FDA 510(k) clearance?

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. received FDA 510(k) clearance on 2016-08-04, under 510(k) number K153551.

Who is the listed applicant for ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.?

The FDA 510(k) record lists Axis-Shield Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.?

The FDA product code for ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. is NHX.

Ensayos clínicos relacionados

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Otros registros que enlistan a Axis-Shield Diagnostics Limited como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K183088ADVIA Centaur Eritropoyetina (EPO) ensayoK182012ADVIA Centaur Calcitonina (CALCT) ensayoK160757ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Ensayo, ADVIA Centaur Active-B12(AB12) Control de Calidad y Materiales de Curva Maestra (MCM) de ADVIA Centaur Active-B12 (AB12)

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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