Cholesterol2
K号: K203597 · 2022-06-30
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决定日期2022-06-30
产品代码CHH
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。
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器械摘要
Cholesterol2 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 2022-06-30 under 510(k) number K203597. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Cholesterol2?
Cholesterol2 is a medical device that received FDA 510(k) clearance on 2022-06-30. The listed applicant is Abbott Ireland Diagnostics Division. The 510(k) number is K203597.
When did Cholesterol2 receive FDA 510(k) clearance?
Cholesterol2 received FDA 510(k) clearance on 2022-06-30, under 510(k) number K203597.
Who is the listed applicant for Cholesterol2?
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 Cholesterol2?
The FDA product code for Cholesterol2 is CHH.
相关临床试验
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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：CHH）
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。
K251091LipidsTruvian HealthK232404胆固醇；高密度脂蛋白胆固醇；低密度脂蛋白胆固醇；甘油三酯Medicon Hellas S.AK190490VITROS XT 化学产品 TRIG-CHOL 试纸Ortho-Clinical Diagnostics, Inc.K181373延长脂质面板检测Laboratory Corporation of America HoldingsK180504Mission 脂质面板监测系统ACON Laboratories, Inc.K163406Mission 胆固醇监测系统，Mission 胆固醇专业监测系统ACON Laboratories, 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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