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FDA 510(k)

VITROS 化学产品 Cl-滑片，VITROS 化学产品 ECO2 滑片，VITROS 化学产品 GLU 滑片

K号: K182072 · 2018-10-30

申请人Ortho-Clinical Diagnostics, Inc.
决定日期2018-10-30
产品代码CGZ
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 Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU 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 2018-10-30 under 510(k) number K182072. The device is classified under product code CGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides?

VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides is a medical device that received FDA 510(k) clearance on 2018-10-30. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K182072.

When did VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides receive FDA 510(k) clearance?

VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides received FDA 510(k) clearance on 2018-10-30, under 510(k) number K182072.

Who is the listed applicant for VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU 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 Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides?

The FDA product code for VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides is CGZ.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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。

K252393VITROS 免疫诊断产品 hs 肌酸激酶同工酶I试剂套装K210858VITROS 化学产品 PHBR 胶片K191316VITROS XT 化学产品 ALB-TP 薄膜K190807VITROS XT 化学产品 TBIL-ALKP 试纸K190520VITROS XT 化学产品 GLU-Ca 试纸K190490VITROS XT 化学产品 TRIG-CHOL 试纸

查看所有 11 个设备 →

相关器械（代码：CGZ）

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。

K170320Alinity c ICT样本稀释液Abbott LaboratoriesK162020VITROS 化学产品 Cl- 滑片Ortho Clinical Diagnostics

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。

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