FDA 510(k)

Great Basin Bordetella直接測試

K 號：K170284 · 2017-03-31

決定日期2017-03-31

產品代碼OZZ

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

Great Basin Bordetella Direct Test is the device name listed in this FDA 510(k) record. The listed applicant is Great Basin Scientific, Inc.. It received FDA 510(k) clearance on 2017-03-31 under 510(k) number K170284. The device is classified under product code OZZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Great Basin Bordetella Direct Test?

Great Basin Bordetella Direct Test is a medical device that received FDA 510(k) clearance on 2017-03-31. The listed applicant is Great Basin Scientific, Inc.. The 510(k) number is K170284.

When did Great Basin Bordetella Direct Test receive FDA 510(k) clearance?

Great Basin Bordetella Direct Test received FDA 510(k) clearance on 2017-03-31, under 510(k) number K170284.

Who is the listed applicant for Great Basin Bordetella Direct Test?

The FDA 510(k) record lists Great Basin Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Great Basin Bordetella Direct Test?

The FDA product code for Great Basin Bordetella Direct Test is OZZ.

其他以 Great Basin Scientific, 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：OZZ）

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。

K243753cobas liat 布氏菌屬核酸檢測面板Roche Molecular Systems, Inc.K183223Simplexa Bordetella Direct，Simplexa Bordetella 正規控制組包Diasorin Molecular, LLC K173498Simplexa Bordetella Direct，Simplexa Bordetella 正規控制組包Diasorin Molecular, LLC K181029索拉納波多氏菌完整試驗Quidel Corporation K163626ARIES 博德特菌試劑；ARIES 博德特菌試劑實驗方案文件套件Luminex Corporation

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