ALFIS维生素D，ALFIS-3分析仪
K号: K221817 · 2023-09-22
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决定日期2023-09-22
产品代码MRG
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
ALFIS Vitamin D, ALFIS-3 Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Inc.,. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K221817. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ALFIS Vitamin D, ALFIS-3 Analyzer?
ALFIS Vitamin D, ALFIS-3 Analyzer is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Immunostics Inc.,. The 510(k) number is K221817.
When did ALFIS Vitamin D, ALFIS-3 Analyzer receive FDA 510(k) clearance?
ALFIS Vitamin D, ALFIS-3 Analyzer received FDA 510(k) clearance on 2023-09-22, under 510(k) number K221817.
Who is the listed applicant for ALFIS Vitamin D, ALFIS-3 Analyzer?
The FDA 510(k) record lists Immunostics Inc., as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ALFIS Vitamin D, ALFIS-3 Analyzer?
The FDA product code for ALFIS Vitamin D, ALFIS-3 Analyzer is MRG.
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Immunostics 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：MRG）
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。
K232587MAGLUMI 25-OH 维生素D, MAGLUMI X3 全自动化学发光免疫分析仪Shenzhen New Industries Biomedical Engineering Co., Ltd.K223503Access 25(OH)维生素D总Beckman Coulter, Inc.K210901Elecsys 维生素 D 总量 IIIRoche DiagnosticsK200509ADVIA Centaur 维生素D总 (VitD)Siemens Healthcare Diagnostics, Inc.K191499MAGLUMI 2000 25-OH 维生素DShenzhen New Industries Biomedical Engineering Co., Ltd.K180577BioPlex 2200 25-OH 维生素 D 试剂盒Bio-Rad Laboratories
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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