cobas CT/NG用於cobas 6800/8800系統
K 號：K173887 · 2018-03-21
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器材摘要
cobas CT/NG for use on cobas 6800/8800 systems is the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2018-03-21 under 510(k) number K173887. 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 cobas CT/NG for use on cobas 6800/8800 systems?
cobas CT/NG for use on cobas 6800/8800 systems is a medical device that received FDA 510(k) clearance on 2018-03-21. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K173887.
When did cobas CT/NG for use on cobas 6800/8800 systems receive FDA 510(k) clearance?
cobas CT/NG for use on cobas 6800/8800 systems received FDA 510(k) clearance on 2018-03-21, under 510(k) number K173887.
Who is the listed applicant for cobas CT/NG for use on cobas 6800/8800 systems?
FDA 510(k) 記錄將羅氏分子系統公司（Roche Molecular Systems, 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 cobas CT/NG for use on cobas 6800/8800 systems?
The FDA product code for cobas CT/NG for use on cobas 6800/8800 systems is LSL.
相關臨床試驗
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。
其他以 Roche Molecular Systems, 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。
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。
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