FDA 510(k)

MBT Sepsityper

K-Number: K193419 · 2020-12-27

Decision Date2020-12-27

Product CodeQNJ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

MBT Sepsityper 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 2020-12-27 under 510(k) number K193419. The device is classified under product code QNJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MBT Sepsityper?

MBT Sepsityper is a medical device that received FDA 510(k) clearance on 2020-12-27. The listed applicant is Bruker Daltonik GmbH. The 510(k) number is K193419.

When did MBT Sepsityper receive FDA 510(k) clearance?

MBT Sepsityper received FDA 510(k) clearance on 2020-12-27, under 510(k) number K193419.

Who is the listed applicant for MBT Sepsityper?

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 MBT Sepsityper?

The FDA product code for MBT Sepsityper is QNJ.

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.

K163536MALDI Biotyper CA (MBT-CA) System, MBT smart CA System

Related Devices (Code: QNJ)

K240854Accelerate Arc SystemAccelerate Diagnostics, 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.