MALDI Biotyper CA (MBT-CA) System, MBT smart CA System— 510(k) K163536

Substantially Equivalent

Bruker Daltonik GmbH

FDA 510(k) clearance K163536 for MALDI Biotyper CA (MBT-CA) System, MBT smart CA System, Substantially Equivalent on 2017-07-26. Applicant: Bruker Daltonik GmbH.

Clearance details

Applicant: Bruker Daltonik GmbH
Product code: Code PEX
Advisory panel: Microbiology
Date received: 2016-12-16
Decision date: 2017-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bremen, DE

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