碱性磷酸酶2
K号: K223317 · 2023-07-21
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决定日期2023-07-21
产品代码CJE
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
Alkaline Phosphatase2 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 2023-07-21 under 510(k) number K223317. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Alkaline Phosphatase2?
Alkaline Phosphatase2 is a medical device that received FDA 510(k) clearance on 2023-07-21. The listed applicant is Abbott Ireland Diagnostics Division. The 510(k) number is K223317.
When did Alkaline Phosphatase2 receive FDA 510(k) clearance?
Alkaline Phosphatase2 received FDA 510(k) clearance on 2023-07-21, under 510(k) number K223317.
Who is the listed applicant for Alkaline Phosphatase2?
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 Alkaline Phosphatase2?
The FDA product code for Alkaline Phosphatase2 is CJE.
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：CJE）
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。
K251074Tru Liver Health Test PanelTruvian HealthK240468碱性磷酸酶Abbott Laboratories Diagnostics DivisionK191245优米森C1200 ALP，优米森C1200白蛋白HORIBA ABX SASK171971综合代谢面板，skyla临床化学分析仪，Minicare C300临床化学分析仪Lite-On Technology Corp. H.S.P.B.K171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)K162275Randox RX Daytona Plus 碱性磷酸酶 (ALP)Randox Laboratories Limited
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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