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FDA 510(k)

MALDI BIOTYPER CA (MBT-CA) SYSTEM

K-Number: K130831 · 2013-11-21

ApplicantBruker Daltonics, Inc.
Decision Date2013-11-21
Product CodePEX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MALDI BIOTYPER CA (MBT-CA) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bruker Daltonics, Inc.. It received FDA 510(k) clearance on 2013-11-21 under 510(k) number K130831. 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?

MALDI BIOTYPER CA (MBT-CA) SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-21. The listed applicant is Bruker Daltonics, Inc.. The 510(k) number is K130831.

When did MALDI BIOTYPER CA (MBT-CA) SYSTEM receive FDA 510(k) clearance?

MALDI BIOTYPER CA (MBT-CA) SYSTEM received FDA 510(k) clearance on 2013-11-21, under 510(k) number K130831.

Who is the listed applicant for MALDI BIOTYPER CA (MBT-CA) SYSTEM?

The FDA 510(k) record lists Bruker Daltonics, Inc. 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?

The FDA product code for MALDI BIOTYPER CA (MBT-CA) SYSTEM is PEX.

Related Clinical Trials

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.

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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.

K163536MALDI Biotyper CA (MBT-CA) System, MBT smart CA SystemBruker Daltonik GmbHK162950VITEK MSbioMerieux, Inc.

Official Source

View on FDA Database →

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

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