ePlex 仪器
K号: K163652 · 2017-06-09
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决定日期2017-06-09
产品代码NSU
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
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器械摘要
ePlex Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Genmark Diagnostics, Incorporated. It received FDA 510(k) clearance on 2017-06-09 under 510(k) number K163652. The device is classified under product code NSU. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ePlex Instrument?
ePlex Instrument is a medical device that received FDA 510(k) clearance on 2017-06-09. The listed applicant is Genmark Diagnostics, Incorporated. The 510(k) number is K163652.
When did ePlex Instrument receive FDA 510(k) clearance?
ePlex Instrument received FDA 510(k) clearance on 2017-06-09, under 510(k) number K163652.
Who is the listed applicant for ePlex Instrument?
The FDA 510(k) record lists Genmark Diagnostics, Incorporated as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ePlex Instrument?
The FDA product code for ePlex Instrument is NSU.
相关临床试验
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列明Genmark Diagnostics, Incorporated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。
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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