Panther Fusion GI Expanded Bacterial Assay
K号: K251993 · 2025-09-25
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决定日期2025-09-25
产品代码PCH
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器械摘要
Panther Fusion GI Expanded Bacterial Assay is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2025-09-25 under 510(k) number K251993. 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 Panther Fusion GI Expanded Bacterial Assay?
Panther Fusion GI Expanded Bacterial Assay is a medical device that received FDA 510(k) clearance on 2025-09-25. The listed applicant is Hologic, Inc.. The 510(k) number is K251993.
When did Panther Fusion GI Expanded Bacterial Assay receive FDA 510(k) clearance?
Panther Fusion GI Expanded Bacterial Assay received FDA 510(k) clearance on 2025-09-25, under 510(k) number K251993.
Who is the listed applicant for Panther Fusion GI Expanded Bacterial Assay?
FDA 510(k)记录中列出了Hologic, Inc.为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for Panther Fusion GI Expanded Bacterial Assay?
The FDA product code for Panther Fusion GI Expanded Bacterial Assay 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。
列明Hologic, 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：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 AssayHologicK250324QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH
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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