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FDA 510(k)

QUANTA Flash Calprotectin 试剂，QUANTA Flash Calprotectin 校准器，QUANTA Flash Calprotectin 控制品，QUANTA Flash Calprotectin 提取缓冲液

K号: K170993 · 2017-12-22

申请人Inova Diagnostics, Inc.
决定日期2017-12-22
产品代码NXO
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决定实质等同

器械摘要

QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-12-22 under 510(k) number K170993. The device is classified under product code NXO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer?

QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer is a medical device that received FDA 510(k) clearance on 2017-12-22. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K170993.

When did QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer receive FDA 510(k) clearance?

QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer received FDA 510(k) clearance on 2017-12-22, under 510(k) number K170993.

Who is the listed applicant for QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer?

The FDA 510(k) record lists Inova Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer?

The FDA product code for QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer is NXO.

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Inova 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。

K243979Aptiva APS IgA 试剂K223093Aptiva APS IgG 试剂; Aptiva APS IgM 试剂K213403Aptiva CTD 基础试剂K200230Aptiva 慢性炎症性肠病 IgG 试剂K193604Aptiva 慢性炎症性肠病 IgA 试剂K192916NOVA Lite DAPI dsDNA Crithidia luciliae试剂盒

查看所有 16 个设备 →

相关器械（代码：NXO）

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。

K232057BÜHLMANN fCAL® turbo和CALEX® CapBühlmann Laboratories AGK220763ALPCO 肠钙蛋白免疫浊度测定ALPCOK213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc.K191807ALPCO 肠钙蛋白化学发光 ELISA, ALPCO 简便粪便提取装置ALPCOK191718Buhlmann fCAL turbo 和 CALEX CapBuhlmann Laboratories AGK191592CalprestNG, EasyCalEurospital S.P.A.

官方来源

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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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