MALDI Biotyper CA System— 510(k) DEN170081

Unknown

Bruker Daltonik GmbH

FDA 510(k) clearance DEN170081 for MALDI Biotyper CA System, Unknown on 2018-04-20. Applicant: Bruker Daltonik GmbH. Device class: 2.

Clearance details

Applicant: Bruker Daltonik GmbH
Product code: Code QBN
Device class: Class 2
Regulation: 21 CFR 866.3378
Advisory panel: Microbiology
Date received: 2017-09-29
Decision date: 2018-04-20
Decision: Unknown
Clearance type: Direct
Location: Bremen, DE

View on FDA.gov ↗

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