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FDA 510(k)

VITROS 化学产品 CRBM 胶片，VITROS 化学产品 CREA 胶片，VITROS 化学产品 TBIL 胶片，VITROS XT 7600 集成系统

K号: K182063 · 2018-10-30

申请人Ortho-Clinical Diagnostics, Inc.
决定日期2018-10-30
产品代码JFY
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 CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System 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 K182063. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System?

VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System 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 K182063.

When did VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System receive FDA 510(k) clearance?

VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System received FDA 510(k) clearance on 2018-10-30, under 510(k) number K182063.

Who is the listed applicant for VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System?

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 CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System?

The FDA product code for VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System is JFY.

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：JFY）

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。

K252619QSCHECK UISACRQstag, Inc.K212223Atellica CH 酶法肌酐_3 (ECre3)Siemens Healthcare Diagnostics, Inc.K193649优米森C1200肌酐PAPHORIBA ABX SASK182384ACR LAB 尿液分析测试系统Healthy.Io, Ltd.K183555GEM Premier ChemSTATInstrumentation Laboratory COK182038URiSCAN 10ACR 尿试纸，用于 URiSCAN Optima 尿分析仪Yd Diagnostics Corporation

官方来源

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