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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 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.

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. 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.

Other records listing Bruker Daltonik GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193419MBT Sepsityper

Related Devices (Code: PEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162950VITEK MSbioMerieux, Inc.

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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