真儿童肾脏健康检测组合；真分析器
K号: K251058 · 2025-11-26
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决定日期2025-11-26
产品代码CGX
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
Tru Kidney Health Test Panel; Tru Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Truvian Health. It received FDA 510(k) clearance on 2025-11-26 under 510(k) number K251058. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Tru Kidney Health Test Panel; Tru Analyzer?
Tru Kidney Health Test Panel; Tru Analyzer is a medical device that received FDA 510(k) clearance on 2025-11-26. The listed applicant is Truvian Health. The 510(k) number is K251058.
When did Tru Kidney Health Test Panel; Tru Analyzer receive FDA 510(k) clearance?
Tru Kidney Health Test Panel; Tru Analyzer received FDA 510(k) clearance on 2025-11-26, under 510(k) number K251058.
Who is the listed applicant for Tru Kidney Health Test Panel; Tru Analyzer?
The FDA 510(k) record lists Truvian Health as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tru Kidney Health Test Panel; Tru Analyzer?
The FDA product code for Tru Kidney Health Test Panel; Tru Analyzer is CGX.
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。
列明Truvian Health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。
相关器械（代码：CGX）
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。
K252206Nova Allegro UACR检测，Nova Allegro分析仪Nova Biomedical CorporationK242685Atellica® CH 创氨酸_3 (Crea3)Siemens Healthcare Diagnostics, Inc.K221813Nova Allegro UACR检测，Nova Allegro分析仪Nova Biomedical CorporationK210452肌酐2Abbott Ireland Diagnostics DivisionK161494Atellica CH 肌酐_2 (Crea_2)，Atellica CH 化学校准器 (CHEM CAL)Siemens Healthcare Diagnostics, Inc.
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。
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