FDA 510(k)

山貓融合內分泌系統廣範細菌試驗

K 號：K251993 · 2025-09-25

決定日期2025-09-25

產品代碼PCH

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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) 記錄將霍洛基克公司（Hologic, Inc.）列為申請人。這並不單獨確立設備製造商。

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.

其他以 Hologic, Inc. 為申請人之記錄

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相關器械（代碼：PCH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253722LIAISON PLEX 消化道柔軟性試驗Luminex Corporation K254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH K251721Xpert GI PanelCepheid K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH K251868山貓融合胃腸細菌試驗Hologic K250324QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。