EasyScreen 胃肠道寄生虫检测试剂盒
K号: K232672 · 2024-05-29
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决定日期2024-05-29
产品代码PCH
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器械摘要
EasyScreen Gastrointestinal Parasite Detection Kit is the device name listed in this FDA 510(k) record. The listed applicant is Genetic Signatures Limited. It received FDA 510(k) clearance on 2024-05-29 under 510(k) number K232672. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EasyScreen Gastrointestinal Parasite Detection Kit?
EasyScreen Gastrointestinal Parasite Detection Kit is a medical device that received FDA 510(k) clearance on 2024-05-29. The listed applicant is Genetic Signatures Limited. The 510(k) number is K232672.
When did EasyScreen Gastrointestinal Parasite Detection Kit receive FDA 510(k) clearance?
EasyScreen Gastrointestinal Parasite Detection Kit received FDA 510(k) clearance on 2024-05-29, under 510(k) number K232672.
Who is the listed applicant for EasyScreen Gastrointestinal Parasite Detection Kit?
The FDA 510(k) record lists Genetic Signatures Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EasyScreen Gastrointestinal Parasite Detection Kit?
The FDA product code for EasyScreen Gastrointestinal Parasite Detection Kit is PCH.
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。
相关器械（代码：PCH）
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。
K253722LIAISON PLEX 胃肠道灵活检测Luminex CorporationK254032QIAstat-Dx 胃肠道检测板 2；QIAstat-Dx GI Panel 2 Mini B&V；QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251721Xpert GI 面板CepheidK252329QIAstat-Dx 胃肠道检测板 2；QIAstat-Dx GI Panel 2 Mini B&V；QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251868Panther Fusion GI Bacterial AssayHologicK251993Panther Fusion GI Expanded Bacterial AssayHologic, Inc.
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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