FDA 510(k)

VITROS 免疫诊断产品总β-hCG II 试剂套装

K号: K233581 · 2024-05-08

决定日期2024-05-08

产品代码DHA

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 Immunodiagnostic Products Total ß-hCG II 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 2024-05-08 under 510(k) number K233581. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack?

VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack is a medical device that received FDA 510(k) clearance on 2024-05-08. The listed applicant is Ortho Clinical Diagnostics. The 510(k) number is K233581.

When did VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack receive FDA 510(k) clearance?

VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack received FDA 510(k) clearance on 2024-05-08, under 510(k) number K233581.

Who is the listed applicant for VITROS Immunodiagnostic Products Total ß-hCG II 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 Total ß-hCG II Reagent Pack?

The FDA product code for VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack is DHA.

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 K221197VITROS 免疫诊断产品完整 PTH II 试剂套装 K231517VITROS 免疫诊断产品 CEA 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 →

相关器械（代码：DHA）

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。

K223690iFlash-HCG; 化学发光免疫分析仪（型号：iFlash 3000-C）Shenzhen Yhlo Biotech Co., Ltd.K230937Alinity i 总β-hCG试剂套件，GLP系统追踪Abbott Laboratories K230790Alinity i 总β-hCG试剂套件，Alinity c 葡萄糖试剂套件，Alinity c ICT样本稀释液，Alinity ci系列Abbott Laboratories K221990Access 总βhCG (5th IS)Beckman Coulter, Inc.K212221Diazyme DZ-Lite iFlash 总β-hCG 测定，Diazyme DZ-Lite iFlash 1800 化学发光免疫测定分析仪Diazyme Laboratories, Inc.K203227Elecsys HCG STATRoche Diagnostics

官方来源

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