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FDA 510(k)

Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application

N.º K: K181599 · 2019-03-18

SolicitanteBeckman Coulter
Fecha de decisión2019-03-18
Código de productoQFS
Comité asesorMI
DecisiónSubstantially Equivalent

Resumen del dispositivo

Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter. It received FDA 510(k) clearance on 2019-03-18 under 510(k) number K181599. The device is classified under product code QFS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application?

Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application is a medical device that received FDA 510(k) clearance on 2019-03-18. The listed applicant is Beckman Coulter. The 510(k) number is K181599.

When did Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application receive FDA 510(k) clearance?

Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application received FDA 510(k) clearance on 2019-03-18, under 510(k) number K181599.

Who is the listed applicant for Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application?

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

What is the FDA product code for Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application?

The FDA product code for Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application is QFS.

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Otros registros que enlistan a Beckman Coulter 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.

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Ver todos los 7 dispositivos →

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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