FDA 510(k)

BACT/ALERT MP試劑系統

K 號：K190405 · 2019-05-15

決定日期2019-05-15

產品代碼MDB

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

BACT/ALERT MP Reagent System is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2019-05-15 under 510(k) number K190405. The device is classified under product code MDB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BACT/ALERT MP Reagent System?

BACT/ALERT MP Reagent System is a medical device that received FDA 510(k) clearance on 2019-05-15. The listed applicant is bioMerieux, Inc.. The 510(k) number is K190405.

When did BACT/ALERT MP Reagent System receive FDA 510(k) clearance?

BACT/ALERT MP Reagent System received FDA 510(k) clearance on 2019-05-15, under 510(k) number K190405.

Who is the listed applicant for BACT/ALERT MP Reagent System?

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

What is the FDA product code for BACT/ALERT MP Reagent System?

The FDA product code for BACT/ALERT MP Reagent System is MDB.

其他以 bioMerieux, 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：MDB）

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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官方來源

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