FDA 510(k)

HDL-胆固醇Gen.4

K号: K162593 · 2016-10-19

决定日期2016-10-19

产品代码LBS

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

HDL-Cholesterol Gen.4 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 2016-10-19 under 510(k) number K162593. The device is classified under product code LBS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HDL-Cholesterol Gen.4?

HDL-Cholesterol Gen.4 is a medical device that received FDA 510(k) clearance on 2016-10-19. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K162593.

When did HDL-Cholesterol Gen.4 receive FDA 510(k) clearance?

HDL-Cholesterol Gen.4 received FDA 510(k) clearance on 2016-10-19, under 510(k) number K162593.

Who is the listed applicant for HDL-Cholesterol Gen.4?

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 HDL-Cholesterol Gen.4?

The FDA product code for HDL-Cholesterol Gen.4 is LBS.

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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官方来源

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