Hipro 糖化血红蛋白 (HbA1c) 测试系统
K号: K220999 · 2024-09-12
广告
决定日期2024-09-12
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
Hipro Glycosylated Hemoglobin (HbA1c) Test System is the device name listed in this FDA 510(k) record. The listed applicant is Shijiazhuang Hipro Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-09-12 under 510(k) number K220999. 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 Hipro Glycosylated Hemoglobin (HbA1c) Test System?
Hipro Glycosylated Hemoglobin (HbA1c) Test System is a medical device that received FDA 510(k) clearance on 2024-09-12. The listed applicant is Shijiazhuang Hipro Biotechnology Co., Ltd.. The 510(k) number is K220999.
When did Hipro Glycosylated Hemoglobin (HbA1c) Test System receive FDA 510(k) clearance?
Hipro Glycosylated Hemoglobin (HbA1c) Test System received FDA 510(k) clearance on 2024-09-12, under 510(k) number K220999.
Who is the listed applicant for Hipro Glycosylated Hemoglobin (HbA1c) Test System?
The FDA 510(k) record lists Shijiazhuang Hipro Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hipro Glycosylated Hemoglobin (HbA1c) Test System?
The FDA product code for Hipro Glycosylated Hemoglobin (HbA1c) Test System 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。
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。
K252749Medconn 8K 糖化血红蛋白测试系统Shanghai Medconn Medical Technology Co., Ltd.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.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
在 FDA 数据库中查看 →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。
广告