FDA 510(k)

Alinity c ICT样本稀释液

K号: K170320 · 2017-10-24

决定日期2017-10-24

产品代码CGZ

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

Alinity c ICT Sample Diluent is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2017-10-24 under 510(k) number K170320. The device is classified under product code CGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Alinity c ICT Sample Diluent?

Alinity c ICT Sample Diluent is a medical device that received FDA 510(k) clearance on 2017-10-24. The listed applicant is Abbott Laboratories. The 510(k) number is K170320.

When did Alinity c ICT Sample Diluent receive FDA 510(k) clearance?

Alinity c ICT Sample Diluent received FDA 510(k) clearance on 2017-10-24, under 510(k) number K170320.

Who is the listed applicant for Alinity c ICT Sample Diluent?

FDA 510(k)记录显示，申请人为阿伯特实验室。这本身并不能确立该设备的制造商。

What is the FDA product code for Alinity c ICT Sample Diluent?

The FDA product code for Alinity c ICT Sample Diluent is CGZ.

列明Abbott Laboratories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。

K262156抗HCV Next K252424抗HCV Next K243500ARCHITECT 链霉素 K243168Alinity i 风疹IgG K243283Alinity h系列系统 K233932Alinity i Toxo IgM

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官方来源

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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。