SmartLyte® Plus电解质分析仪Na+/K+/Cl-/Ca++/Li+
K号: K200544 · 2020-10-01
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决定日期2020-10-01
产品代码CEM
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
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ is the device name listed in this FDA 510(k) record. The listed applicant is Diamond Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-10-01 under 510(k) number K200544. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+?
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ is a medical device that received FDA 510(k) clearance on 2020-10-01. The listed applicant is Diamond Diagnostics, Inc.. The 510(k) number is K200544.
When did SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ receive FDA 510(k) clearance?
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ received FDA 510(k) clearance on 2020-10-01, under 510(k) number K200544.
Who is the listed applicant for SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+?
The FDA 510(k) record lists Diamond Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+?
The FDA product code for SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ is CEM.
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相关器械（代码：CEM）
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。
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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