HSV 1 & 2 ELITe MGB 套件; ELITe InGenius
K号: K180559 · 2018-10-29
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申请人Elitechgroup
决定日期2018-10-29
产品代码PGI
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决定实质等同
器械摘要
HSV 1 & 2 ELITe MGB Kit; ELITe InGenius is the device name listed in this FDA 510(k) record. The listed applicant is Elitechgroup. It received FDA 510(k) clearance on 2018-10-29 under 510(k) number K180559. The device is classified under product code PGI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the HSV 1 & 2 ELITe MGB Kit; ELITe InGenius?
HSV 1 & 2 ELITe MGB Kit; ELITe InGenius is a medical device that received FDA 510(k) clearance on 2018-10-29. The listed applicant is Elitechgroup. The 510(k) number is K180559.
When did HSV 1 & 2 ELITe MGB Kit; ELITe InGenius receive FDA 510(k) clearance?
HSV 1 & 2 ELITe MGB Kit; ELITe InGenius received FDA 510(k) clearance on 2018-10-29, under 510(k) number K180559.
Who is the listed applicant for HSV 1 & 2 ELITe MGB Kit; ELITe InGenius?
The FDA 510(k) record lists Elitechgroup as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HSV 1 & 2 ELITe MGB Kit; ELITe InGenius?
The FDA product code for HSV 1 & 2 ELITe MGB Kit; ELITe InGenius is PGI.
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Elitechgroup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：PGI）
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。
K233349Alinity m HSV 1 & 2 / VZVAbbott Molecular, Inc.K232286Savanna HSV 1+2/VZV 测定，Savanna HSV 1+2/VZV 控制套件，Savanna 仪器Quidel CorporationK192376Simplexa VZV 棉签直接检测，Simplexa VZV 阳性对照包Diasorin Molecular, LLCK173798Simplexa HSV 1 & 2 直接检测，Simplexa HSV 1 & 2 阳性对照包Diasorin Molecular, LLCK162451Solana HSV 1+2/VZV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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