FDA 510(k)

Medconn 8K 糖化血红蛋白测试系统

K号: K252749 · 2026-01-06

申请人Shanghai Medconn Medical Technology Co., Ltd.

决定日期2026-01-06

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

Medconn 8K Glycated Hemoglobin Test System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Medconn Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-01-06 under 510(k) number K252749. 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 Medconn 8K Glycated Hemoglobin Test System?

Medconn 8K Glycated Hemoglobin Test System is a medical device that received FDA 510(k) clearance on 2026-01-06. The listed applicant is Shanghai Medconn Medical Technology Co., Ltd.. The 510(k) number is K252749.

When did Medconn 8K Glycated Hemoglobin Test System receive FDA 510(k) clearance?

Medconn 8K Glycated Hemoglobin Test System received FDA 510(k) clearance on 2026-01-06, under 510(k) number K252749.

Who is the listed applicant for Medconn 8K Glycated Hemoglobin Test System?

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

What is the FDA product code for Medconn 8K Glycated Hemoglobin Test System?

The FDA product code for Medconn 8K Glycated Hemoglobin Test System is PDJ.

列明Shanghai Medconn Medical Technology Co., Ltd.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。

K242911Medconn 糖化血红蛋白测试系统

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。

K250073东芝自动糖化血红蛋白分析仪 HLC-723GR01Tosoh Bioscience, Inc.K242911Medconn 糖化血红蛋白测试系统Shanghai Medconn Medical Technology Co., Ltd.K220999Hipro 糖化血红蛋白 (HbA1c) 测试系统Shijiazhuang Hipro Biotechnology Co., Ltd.K200904东芝自动糖化血红蛋白分析仪 HLC-723G8Tosoh Bioscience, Inc.K200256ADVIA 化学酶法血红蛋白Ale (Alc_E) 测定Siemens Healthcare Diagnostics, Inc.K193053Tina-quant 血红蛋白A1cDx 通用.3Roche Diagnostics Operations (Rdo)

官方来源

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