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FDA 510(k)

Simplexa 肠炎弧菌直接检测；Simplexa 肠炎弧菌阳性对照包

K号: K163085 · 2017-02-14

申请人Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC
决定日期2017-02-14
产品代码OZN
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决定实质等同

器械摘要

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack is the device name listed in this FDA 510(k) record. The listed applicant is Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2017-02-14 under 510(k) number K163085. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack?

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack is a medical device that received FDA 510(k) clearance on 2017-02-14. The listed applicant is Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC. The 510(k) number is K163085.

When did Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack receive FDA 510(k) clearance?

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack received FDA 510(k) clearance on 2017-02-14, under 510(k) number K163085.

Who is the listed applicant for Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack?

The FDA 510(k) record lists Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack?

The FDA product code for Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack is OZN.

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：OZN）

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。

K260045cobas® Cdiff 核酸检测，用于 cobas® Liat® 系统（07454945190）；cobas® Cdiff 阳性及阴性对照试剂盒，用于 cobas® Liat® 系统（07454970190）Roche Molecular Systems, Inc.K243730Xpert 肠道难辨梭菌/流行病学Cepheid®K232092Great Basin Toxigenic C. difficile Direct Test (CDF2)Vela Operations USAK212427cobas Cdiff 核酸检测，适用于 cobas Liat 系统Roche Molecular Systems, Inc.K210385cobas Cdiff 核酸检测，适用于 cobas Liat 系统Roche Molecular Systems, Inc.K172569GenePOC CDiffGenepoc, Inc.

官方来源

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