MBT Sepsityper— 510(k) K193419

Substantially Equivalent

Bruker Daltonik GmbH

FDA 510(k) clearance K193419 for MBT Sepsityper, Substantially Equivalent on 2020-12-27. Applicant: Bruker Daltonik GmbH. Device class: 2.

Clearance details

Applicant: Bruker Daltonik GmbH
Product code: Code QNJ
Device class: Class 2
Regulation: 21 CFR 866.3378
Advisory panel: Microbiology
Date received: 2019-12-09
Decision date: 2020-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bremen, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.