GenePOC GBS LB
K号: K170557 · 2017-05-25
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决定日期2017-05-25
产品代码NJR
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器械摘要
GenePOC GBS LB is the device name listed in this FDA 510(k) record. The listed applicant is Genepoc, Inc.. It received FDA 510(k) clearance on 2017-05-25 under 510(k) number K170557. The device is classified under product code NJR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the GenePOC GBS LB?
GenePOC GBS LB is a medical device that received FDA 510(k) clearance on 2017-05-25. The listed applicant is Genepoc, Inc.. The 510(k) number is K170557.
When did GenePOC GBS LB receive FDA 510(k) clearance?
GenePOC GBS LB received FDA 510(k) clearance on 2017-05-25, under 510(k) number K170557.
Who is the listed applicant for GenePOC GBS LB?
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 GBS LB?
The FDA product code for GenePOC GBS LB is NJR.
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。
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。
相关器械（代码：NJR）
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。
K222638Xpert® Xpress GBS，GeneXpert® Dx 系统，GeneXpert® Infinity 系统CepheidK203429Xpert GBS LB XC，GeneXpert Dx 系统，GeneXpert Infinity 系统CepheidK182467Simplexa GBS 直接检测，Simplexa GBS 阳性对照包Diasorin Molecular, LLCK181156Panther Fusion GBS AssayDiagenodeK173725NeuMoDx GBS检测Neumodx Molecular, Inc.K173250Solana GBS检测。Quidel Corporation
官方来源
在 FDA 数据库中查看 →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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