FDA 510(k)

Aptima Combo 2 Assay (Panther System)

K 號：K180681 · 2018-06-13

決定日期2018-06-13

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 Combo 2 Assay (Panther System) is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2018-06-13 under 510(k) number K180681. 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 Combo 2 Assay (Panther System)?

Aptima Combo 2 Assay (Panther System) is a medical device that received FDA 510(k) clearance on 2018-06-13. The listed applicant is Hologic, Inc.. The 510(k) number is K180681.

When did Aptima Combo 2 Assay (Panther System) receive FDA 510(k) clearance?

Aptima Combo 2 Assay (Panther System) received FDA 510(k) clearance on 2018-06-13, under 510(k) number K180681.

Who is the listed applicant for Aptima Combo 2 Assay (Panther System)?

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 Combo 2 Assay (Panther System)?

The FDA product code for Aptima Combo 2 Assay (Panther System) 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。

K254090I-View®K262792Brevera 結石系統搭配 CorLumina 圖像技術（BREVDISP09）K253634CoolSeal Generator® (CSL-200-90)K251993山貓融合內分泌系統廣範細菌試驗 K243341Genius AI偵測 2.0 K243396Aptima SARS-CoV-2 檢測試劑

查看所有 45 項裝置 →

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。

K231329Aptima 黏膜壞死桿菌檢測試劑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

在 FDA 資料庫中查看 →

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。