FDA 510(k)

NG-Test CARBA 5

K 號：K191889 · 2019-10-02

決定日期2019-10-02

產品代碼PTJ

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

NG-Test CARBA 5 is the device name listed in this FDA 510(k) record. The listed applicant is Ng Biotech. It received FDA 510(k) clearance on 2019-10-02 under 510(k) number K191889. The device is classified under product code PTJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NG-Test CARBA 5?

NG-Test CARBA 5 is a medical device that received FDA 510(k) clearance on 2019-10-02. The listed applicant is Ng Biotech. The 510(k) number is K191889.

When did NG-Test CARBA 5 receive FDA 510(k) clearance?

NG-Test CARBA 5 received FDA 510(k) clearance on 2019-10-02, under 510(k) number K191889.

Who is the listed applicant for NG-Test CARBA 5?

The FDA 510(k) record lists Ng Biotech as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NG-Test CARBA 5?

The FDA product code for NG-Test CARBA 5 is PTJ.

其他以 Ng Biotech 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。

K243499NG-Test® CTX-M 多重

相關器械（代碼：PTJ）

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。

K243499NG-Test® CTX-M 多重Ng Biotech K162385RAPIDEC 卡巴 NPBiomerieux S.A.

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。