FDA 510(k)

GenePOC CDiff

K号: K172569 · 2017-11-22

决定日期2017-11-22

产品代码OZN

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决定实质等同

器械摘要

GenePOC CDiff is the device name listed in this FDA 510(k) record. The listed applicant is Genepoc, Inc.. It received FDA 510(k) clearance on 2017-11-22 under 510(k) number K172569. 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 GenePOC CDiff?

GenePOC CDiff is a medical device that received FDA 510(k) clearance on 2017-11-22. The listed applicant is Genepoc, Inc.. The 510(k) number is K172569.

When did GenePOC CDiff receive FDA 510(k) clearance?

GenePOC CDiff received FDA 510(k) clearance on 2017-11-22, under 510(k) number K172569.

Who is the listed applicant for GenePOC CDiff?

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

What is the FDA product code for GenePOC CDiff?

The FDA product code for GenePOC CDiff is OZN.

列明Genepoc, 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。

K190275GenePOC Carba K183366GenePOC Strep A K170558Revogene K170557GenePOC GBS LB

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 USA K212427cobas 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.K171770cobas Cdiff 核酸检测，适用于 cobas Liat 系统Roche Molecular Systems, Inc.

官方来源

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