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FDA 510(k)

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

K-Number: K163536 · 2017-07-26

ApplicantBruker Daltonik GmbH
Decision Date2017-07-26
Product CodePEX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MALDI Biotyper CA (MBT-CA) System, MBT smart CA System is a medical device manufactured by Bruker Daltonik GmbH. It received FDA 510(k) clearance on 2017-07-26 under approval number K163536. The device is classified under product code PEX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Bruker Daltonik GmbH. The 510(k) number is K163536.

When was MALDI Biotyper CA (MBT-CA) System, MBT smart CA System approved by the FDA?

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

What company makes MALDI Biotyper CA (MBT-CA) System, MBT smart CA System?

MALDI Biotyper CA (MBT-CA) System, MBT smart CA System is manufactured by Bruker Daltonik GmbH.

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.

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Other Devices by Bruker Daltonik GmbH

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Related Devices (Code: PEX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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