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FDA 510(k)

Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application

Número K: K181599 · 2019-03-18

RequerenteBeckman Coulter
Data da decisão2019-03-18
Código do produtoQFS
Comité consultivoMI
DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Beckman Coulter como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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Ver todos os 7 dispositivos →

Fonte oficial

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