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FDA 510(k)

QuikRead go CRP，QuikRead go CRP 验证套件，QuikRead go CRP 控制套件，以及 QuikRead go 仪器

K号: K142993 · 2016-03-10

申请人Orion Diagnostica, OY
决定日期2016-03-10
产品代码DCK
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决定实质等同

器械摘要

QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Orion Diagnostica, OY. It received FDA 510(k) clearance on 2016-03-10 under 510(k) number K142993. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument?

QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument is a medical device that received FDA 510(k) clearance on 2016-03-10. The listed applicant is Orion Diagnostica, OY. The 510(k) number is K142993.

When did QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument receive FDA 510(k) clearance?

QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument received FDA 510(k) clearance on 2016-03-10, under 510(k) number K142993.

Who is the listed applicant for QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument?

The FDA 510(k) record lists Orion Diagnostica, OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument?

The FDA product code for QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument is DCK.

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

相关器械（代码：DCK）

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。

K242170K-ASSAY CRP（版本2）Kamiya Biomedical Company, LLCK201256Procise CRP，ProciseDx 分析仪，ProciseDx 校准卡Procise DiagnosticsK192028优米森C1200 CRPHORIBA ABX SASK192118CRP VarioSENTINEL CH. SpAK191993优米森C1200 CRPHORIBA ABX SASK160712VITROS 化学产品 hsCRP 试剂Ortho Clinical Diagnostics

官方来源

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