FDA 510(k)

xTAG 胆囊纤维化60套件v2，xTAG数据分析软件（TDAS）CFTR

K号: K163336 · 2016-12-15

决定日期2016-12-15

产品代码NUA

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决定Unknown

器械摘要

xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Molecular Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-12-15 under 510(k) number K163336. The device is classified under product code NUA. It was reviewed by the IM advisory panel. FDA Decision: Unknown.

常见问题

What is the xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR?

xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR is a medical device that received FDA 510(k) clearance on 2016-12-15. The listed applicant is Luminex Molecular Diagnostics, Inc.. The 510(k) number is K163336.

When did xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR receive FDA 510(k) clearance?

xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR received FDA 510(k) clearance on 2016-12-15, under 510(k) number K163336.

Who is the listed applicant for xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR?

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

What is the FDA product code for xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR?

The FDA product code for xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR is NUA.

列明Luminex Molecular 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。

K242613NxTAG®呼吸道病原体检测板 K231758NxTAG呼吸道病原体检测板v2 (NxTAG RPP v2)K193167NxTAG呼吸道病原体检测板，NxTAG呼吸道病原体检测板文件，SYNCT软件 K191161xTAG 胃肠道病原体检测板（GPP）K191160xTAG 胃肠道病原体检测板（GPP），xTAG 数据分析软件（TDAS GPP）K183023xTAG 胃肠道病原体检测板（GPP），xTAG 数据分析软件（TDAS GPP）

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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。