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FDA 510(k)

Unicel DxH 800 细胞分析系统及早期脓毒症指示器应用

K号: K181599 · 2019-03-18

申请人Beckman Coulter
决定日期2019-03-18
产品代码QFS
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决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Beckman Coulter为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K232904Access 酶解素K193124Unicel DxH 800 Coulter 细胞分析系统K182886Cytomics FC 500系列（MPL或MCL）流式细胞仪K183592ClearLLab 10C 面板（B，T，M1，M2），Navios 流式细胞仪，Navios EX 流式细胞仪K181475DxH 520血液分析仪K162897Navios EX 流式细胞仪，6色/2激光，Navios EX 流式细胞仪，8色/2激光，Navios EX 流式细胞仪，10色/3激光

查看所有 7 个设备 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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