FDA 510(k)

Aptima 黏膜壞死桿菌檢測試劑

K 號：K231329 · 2024-01-26

決定日期2024-01-26

產品代碼LSL

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

Aptima Neisseria gonorrhoeae 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 2024-01-26 under 510(k) number K231329. The device is classified under product code LSL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aptima Neisseria gonorrhoeae Assay?

Aptima Neisseria gonorrhoeae Assay is a medical device that received FDA 510(k) clearance on 2024-01-26. The listed applicant is Hologic, Inc.. The 510(k) number is K231329.

When did Aptima Neisseria gonorrhoeae Assay receive FDA 510(k) clearance?

Aptima Neisseria gonorrhoeae Assay received FDA 510(k) clearance on 2024-01-26, under 510(k) number K231329.

Who is the listed applicant for Aptima Neisseria gonorrhoeae 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 Aptima Neisseria gonorrhoeae Assay?

The FDA product code for Aptima Neisseria gonorrhoeae Assay is LSL.

其他以 Hologic, Inc. 為申請人之記錄

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。

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相關器械（代碼：LSL）

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。

K180681Aptima Combo 2 Assay (Panther System)Hologic, Inc.K173887cobas CT/NG用於cobas 6800/8800系統Roche Molecular Systems, Inc.K173840Xpert CT/NGCepheid K163184cobas® CT/NG v2.0 測試Roche Molecular Systems, Inc.

官方來源

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