Atellica® CH 创氨酸_3 (Crea3)
K号: K242685 · 2024-12-04
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决定日期2024-12-04
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
Atellica® CH Creatinine_3 (Crea3) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-12-04 under 510(k) number K242685. 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 Atellica® CH Creatinine_3 (Crea3)?
Atellica® CH Creatinine_3 (Crea3) is a medical device that received FDA 510(k) clearance on 2024-12-04. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K242685.
When did Atellica® CH Creatinine_3 (Crea3) receive FDA 510(k) clearance?
Atellica® CH Creatinine_3 (Crea3) received FDA 510(k) clearance on 2024-12-04, under 510(k) number K242685.
Who is the listed applicant for Atellica® CH Creatinine_3 (Crea3)?
FDA 510(k)记录中列出西门子医疗诊断公司（Siemens Healthcare Diagnostics, Inc.）为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for Atellica® CH Creatinine_3 (Crea3)?
The FDA product code for Atellica® CH Creatinine_3 (Crea3) 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Siemens Healthcare Diagnostics, 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。
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 CorporationK251058真儿童肾脏健康检测组合；真分析器Truvian HealthK221813Nova 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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