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FDA 510(k)

东芝自动糖化血红蛋白分析仪 HLC-723G8

K号: K200904 · 2021-08-05

申请人Tosoh Bioscience, Inc.
决定日期2021-08-05
产品代码PDJ
咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Bioscience, Inc.. It received FDA 510(k) clearance on 2021-08-05 under 510(k) number K200904. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tosoh Automated Glycohemoglobin Analyzer HLC-723G8?

Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is a medical device that received FDA 510(k) clearance on 2021-08-05. The listed applicant is Tosoh Bioscience, Inc.. The 510(k) number is K200904.

When did Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 receive FDA 510(k) clearance?

Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 received FDA 510(k) clearance on 2021-08-05, under 510(k) number K200904.

Who is the listed applicant for Tosoh Automated Glycohemoglobin Analyzer HLC-723G8?

The FDA 510(k) record lists Tosoh Bioscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tosoh Automated Glycohemoglobin Analyzer HLC-723G8?

The FDA product code for Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is PDJ.

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Tosoh Bioscience, Inc.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。

K250073东芝自动糖化血红蛋白分析仪 HLC-723GR01K211199ST AIA-PACK BNP 测定K160113ST AIA-PACK hsE2 校准器套件

相关器械（代码：PDJ）

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。

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