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FDA 510(k)

CP3000 凝血分析仪，Coagpia AT 试剂，Coagpia 校准器，Coagpia 控制套件

K号: K173202 · 2018-05-09

申请人Sekisui Medical Co., Ltd.
决定日期2018-05-09
产品代码JPA
咨询委员会HE 请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set is the device name listed in this FDA 510(k) record. The listed applicant is Sekisui Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-05-09 under 510(k) number K173202. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set?

CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set is a medical device that received FDA 510(k) clearance on 2018-05-09. The listed applicant is Sekisui Medical Co., Ltd.. The 510(k) number is K173202.

When did CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set receive FDA 510(k) clearance?

CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set received FDA 510(k) clearance on 2018-05-09, under 510(k) number K173202.

Who is the listed applicant for CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set?

The FDA 510(k) record lists Sekisui Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set?

The FDA product code for CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set is JPA.

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

相关器械（代码：JPA）

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。

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965自动血凝分析仪CN系列（CN-6000）Sysmex America, Inc.K251024TEG 6s 止血系统 柠檬酸盐：K, KH, RT, FF 测定卡HaemoneticsK243858TEG 6s 止血系统 柠檬酸盐：K, KH, RT, FF 测定卡Haemonetics CorporationK232018Citrated: K, KH, RTH, FFHHaemonetics CorporationK233790ACL TOP 970 CLInstrumentation Laboratory

官方来源

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