FDA 510(k)

ADVIA Centaur 降钙素（CALCT）测定

K号: K182012 · 2018-12-21

决定日期2018-12-21

产品代码JKR

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

ADVIA Centaur Calcitonin (CALCT) assay is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics Limited. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K182012. The device is classified under product code JKR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ADVIA Centaur Calcitonin (CALCT) assay?

ADVIA Centaur Calcitonin (CALCT) assay is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Axis-Shield Diagnostics Limited. The 510(k) number is K182012.

When did ADVIA Centaur Calcitonin (CALCT) assay receive FDA 510(k) clearance?

ADVIA Centaur Calcitonin (CALCT) assay received FDA 510(k) clearance on 2018-12-21, under 510(k) number K182012.

Who is the listed applicant for ADVIA Centaur Calcitonin (CALCT) assay?

The FDA 510(k) record lists Axis-Shield Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA Centaur Calcitonin (CALCT) assay?

The FDA product code for ADVIA Centaur Calcitonin (CALCT) assay is JKR.

列明Axis-Shield Diagnostics Limited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。

K183088ADVIA Centaur 红细胞生成素（EPO）测定 K153551医疗器械监管政策：医疗设备监管规定- ADV坎塔特抗-CCP IgG (aCCP nâ´) 检测试剂包括试剂和校准材料、质量控制材料和曲线材料 nâ´K160757ADVIA Centaur Active-B12 (全反式钴胺素)(AB12) 测定，ADVIA Centaur Active-B12(AB12) 质量控制，以及ADVIA Centaur Active-B12 (AB12) 主曲线材料（MCM）

官方来源

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