FDA 510(k)

MBT 腫血症分類器

K 號：K193419 · 2020-12-27

決定日期2020-12-27

產品代碼QNJ

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

MBT Sepsityper is the device name listed in this FDA 510(k) record. The listed applicant is Bruker Daltonik GmbH. It received FDA 510(k) clearance on 2020-12-27 under 510(k) number K193419. The device is classified under product code QNJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MBT Sepsityper?

MBT Sepsityper is a medical device that received FDA 510(k) clearance on 2020-12-27. The listed applicant is Bruker Daltonik GmbH. The 510(k) number is K193419.

When did MBT Sepsityper receive FDA 510(k) clearance?

MBT Sepsityper received FDA 510(k) clearance on 2020-12-27, under 510(k) number K193419.

Who is the listed applicant for MBT Sepsityper?

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

What is the FDA product code for MBT Sepsityper?

The FDA product code for MBT Sepsityper is QNJ.

其他以 Bruker Daltonik GmbH 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：QNJ）

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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