FDA 510(k)

VITROS XT 化学产品 TRIG-CHOL 试纸

K号: K190490 · 2019-03-27

决定日期2019-03-27

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。

决定实质等同

器械摘要

VITROS XT Chemistry Products TRIG-CHOL Slides is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-03-27 under 510(k) number K190490. 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 VITROS XT Chemistry Products TRIG-CHOL Slides?

VITROS XT Chemistry Products TRIG-CHOL Slides is a medical device that received FDA 510(k) clearance on 2019-03-27. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K190490.

When did VITROS XT Chemistry Products TRIG-CHOL Slides receive FDA 510(k) clearance?

VITROS XT Chemistry Products TRIG-CHOL Slides received FDA 510(k) clearance on 2019-03-27, under 510(k) number K190490.

Who is the listed applicant for VITROS XT Chemistry Products TRIG-CHOL Slides?

The FDA 510(k) record lists Ortho-Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITROS XT Chemistry Products TRIG-CHOL Slides?

The FDA product code for VITROS XT Chemistry Products TRIG-CHOL Slides is CHH.

列明Ortho-Clinical Diagnostics, Inc.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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