FDA 510(k)

科博斯C513分析仪，科博斯C13 Tina-quant HbA1cDx Gen.3检测套件

K号: K160571 · 2016-12-19

决定日期2016-12-19

产品代码PDJ

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决定实质等同

器械摘要

cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2016-12-19 under 510(k) number K160571. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay?

cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay is a medical device that received FDA 510(k) clearance on 2016-12-19. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K160571.

When did cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay receive FDA 510(k) clearance?

cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay received FDA 510(k) clearance on 2016-12-19, under 510(k) number K160571.

Who is the listed applicant for cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay?

The FDA 510(k) record lists Roche Diagnostics Operations (Rdo) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay?

The FDA product code for cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay is PDJ.

列明Roche Diagnostics Operations (Rdo)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。

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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。

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