FDA 510(k)

VITROS 化学产品 GLU 试纸

K号: K163433 · 2017-09-18

决定日期2017-09-18

产品代码CGA

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决定实质等同

器械摘要

VITROS Chemistry Products GLU Slides is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2017-09-18 under 510(k) number K163433. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VITROS Chemistry Products GLU Slides?

VITROS Chemistry Products GLU Slides is a medical device that received FDA 510(k) clearance on 2017-09-18. The listed applicant is Ortho Clinical Diagnostics. The 510(k) number is K163433.

When did VITROS Chemistry Products GLU Slides receive FDA 510(k) clearance?

VITROS Chemistry Products GLU Slides received FDA 510(k) clearance on 2017-09-18, under 510(k) number K163433.

Who is the listed applicant for VITROS Chemistry Products GLU Slides?

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

What is the FDA product code for VITROS Chemistry Products GLU Slides?

The FDA product code for VITROS Chemistry Products GLU Slides is CGA.

列明Ortho Clinical Diagnostics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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