FDA 510(k)

xTAG CYP2D6 套件 v3

K号: K170492 · 2017-08-11

决定日期2017-08-11

产品代码NTI

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决定实质等同

器械摘要

xTAG CYP2D6 Kit v3 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 2017-08-11 under 510(k) number K170492. The device is classified under product code NTI. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the xTAG CYP2D6 Kit v3?

xTAG CYP2D6 Kit v3 is a medical device that received FDA 510(k) clearance on 2017-08-11. The listed applicant is Luminex Molecular Diagnostics, Inc.. The 510(k) number is K170492.

When did xTAG CYP2D6 Kit v3 receive FDA 510(k) clearance?

xTAG CYP2D6 Kit v3 received FDA 510(k) clearance on 2017-08-11, under 510(k) number K170492.

Who is the listed applicant for xTAG CYP2D6 Kit v3?

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 CYP2D6 Kit v3?

The FDA product code for xTAG CYP2D6 Kit v3 is NTI.

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。

器械摘要

常见问题

列明Luminex Molecular Diagnostics, Inc.为申报人的其他记录

相关器械（代码：NTI）

官方来源