FDA 510(k)

VITROS 免疫诊断产品 CA 19-9TM 试剂套装

K号: K231525 · 2023-08-09

决定日期2023-08-09

产品代码NIG

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决定实质等同

器械摘要

VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack 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 2023-08-09 under 510(k) number K231525. The device is classified under product code NIG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack?

VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack is a medical device that received FDA 510(k) clearance on 2023-08-09. The listed applicant is Ortho Clinical Diagnostics. The 510(k) number is K231525.

When did VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack receive FDA 510(k) clearance?

VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack received FDA 510(k) clearance on 2023-08-09, under 510(k) number K231525.

Who is the listed applicant for VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack?

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 Immunodiagnostic Products CA 19-9TM Reagent Pack?

The FDA product code for VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack is NIG.

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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官方来源

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