FDA 510(k)

VITROS 免疫诊断产品 CEA 试剂套装

K号: K231517 · 2023-08-23

决定日期2023-08-23

产品代码DHX

咨询委员会抱歉，您提供的信息不完整，无法进行翻译。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 Immunodiagnostic Products CEA 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 2023-08-23 under 510(k) number K231517. The device is classified under product code DHX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VITROS Immunodiagnostic Products CEA Reagent Pack?

VITROS Immunodiagnostic Products CEA Reagent Pack is a medical device that received FDA 510(k) clearance on 2023-08-23. The listed applicant is Ortho Clinical Diagnostics. The 510(k) number is K231517.

When did VITROS Immunodiagnostic Products CEA Reagent Pack receive FDA 510(k) clearance?

VITROS Immunodiagnostic Products CEA Reagent Pack received FDA 510(k) clearance on 2023-08-23, under 510(k) number K231517.

Who is the listed applicant for VITROS Immunodiagnostic Products CEA 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 CEA Reagent Pack?

The FDA product code for VITROS Immunodiagnostic Products CEA Reagent Pack is DHX.

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。

K241534VITROS 免疫诊断产品梅毒试剂套装 K233581VITROS 免疫诊断产品总β-hCG II 试剂套装 K221197VITROS 免疫诊断产品完整 PTH II 试剂套装 K231525VITROS 免疫诊断产品 CA 19-9TM 试剂套装 K221355VITROS 免疫诊断产品 CA 125 II 试剂套装 K213626维特罗斯 AFP

查看所有 14 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。