肌酐2
K号: K210452 · 2022-03-22
广告
决定日期2022-03-22
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
Creatinine2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Ireland Diagnostics Division. It received FDA 510(k) clearance on 2022-03-22 under 510(k) number K210452. 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 Creatinine2?
Creatinine2 is a medical device that received FDA 510(k) clearance on 2022-03-22. The listed applicant is Abbott Ireland Diagnostics Division. The 510(k) number is K210452.
When did Creatinine2 receive FDA 510(k) clearance?
Creatinine2 received FDA 510(k) clearance on 2022-03-22, under 510(k) number K210452.
Who is the listed applicant for Creatinine2?
The FDA 510(k) record lists Abbott Ireland Diagnostics Division as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Creatinine2?
The FDA product code for Creatinine2 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Abbott Ireland Diagnostics Division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 HealthK242685Atellica® CH 创氨酸_3 (Crea3)Siemens Healthcare Diagnostics, Inc.K221813Nova Allegro UACR检测，Nova Allegro分析仪Nova Biomedical CorporationK161494Atellica 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。
广告