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

Name: FDA 510(k) clearance K163536
Creator: U.S. Food and Drug Administration
Published: 2017-07-26

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. Device class: 2.

Clearance details

Applicant: Bruker Daltonik GmbH
Product code: Code PEX
Device class: Class 2
Regulation: 21 CFR 866.3361
Advisory panel: Microbiology
Date received: 2016-12-16
Decision date: 2017-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bremen, DE

Download summary PDF View on FDA.gov ↗

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K162950 — VITEK MS2017-07-22
K142677 — MALDI Biotyper CA System2015-03-27
K130831 — MALDI BIOTYPER CA (MBT-CA) SYSTEM2013-11-21
DEN130013 — VITEK MS2013-08-21

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