FDA 510(k)

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

K号: K163536 · 2017-07-26

决定日期2017-07-26

产品代码PEX

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决定实质等同

器械摘要

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.

常见问题

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.

列明Bruker Daltonik GmbH为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K193419MBT Sepsityper

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