FDA 510(k)

馬來酸酐質譜生物分類器CA（MBT-CA）系統，MBT智能CA系統

K 號：K163536 · 2017-07-26

決定日期2017-07-26

產品代碼PEX

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

MALDI Biotyper CA (MBT-CA) System, MBT smart CA System 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 2017-07-26 under 510(k) number K163536. The device is classified under product code PEX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MALDI Biotyper CA (MBT-CA) System, MBT smart CA System?

MALDI Biotyper CA (MBT-CA) System, MBT smart CA System is a medical device that received FDA 510(k) clearance on 2017-07-26. The listed applicant is Bruker Daltonik GmbH. The 510(k) number is K163536.

When did MALDI Biotyper CA (MBT-CA) System, MBT smart CA System receive FDA 510(k) clearance?

MALDI Biotyper CA (MBT-CA) System, MBT smart CA System received FDA 510(k) clearance on 2017-07-26, under 510(k) number K163536.

Who is the listed applicant for MALDI Biotyper CA (MBT-CA) System, MBT smart CA System?

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 MALDI Biotyper CA (MBT-CA) System, MBT smart CA System?

The FDA product code for MALDI Biotyper CA (MBT-CA) System, MBT smart CA System is PEX.

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。

K193419MBT 腫血症分類器

相關器械（代碼：PEX）

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。

K162950VITEK MSbioMerieux, Inc.

官方來源

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