MBT Sepsityper
K-Number: K193419 · 2020-12-27
ApplicantBruker Daltonik GmbH
Decision Date2020-12-27
Product CodeQNJ
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
MBT Sepsityper is a medical device manufactured by Bruker Daltonik GmbH. It received FDA 510(k) clearance on 2020-12-27 under approval 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. It is manufactured by Bruker Daltonik GmbH. The 510(k) number is K193419.
When was MBT Sepsityper approved by the FDA?
MBT Sepsityper received FDA 510(k) clearance on 2020-12-27, under approval number K193419.
What company makes MBT Sepsityper?
MBT Sepsityper is manufactured by Bruker Daltonik GmbH.
What is the FDA product code for MBT Sepsityper?
The FDA product code for MBT Sepsityper is QNJ.
Other Devices by Bruker Daltonik GmbH
Related Devices (Code: QNJ)
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.