MALDI BIOTYPER CA (MBT-CA) SYSTEM— 510(k) K130831

Name: FDA 510(k) clearance K130831
Creator: U.S. Food and Drug Administration
Published: 2013-11-21

Substantially Equivalent

Bruker Daltonics, Inc.

FDA 510(k) clearance K130831 for MALDI BIOTYPER CA (MBT-CA) SYSTEM, Substantially Equivalent on 2013-11-21. Applicant: Bruker Daltonics, Inc.. Device class: 2.

Clearance details

Applicant: Bruker Daltonics, Inc.
Product code: Code PEX
Device class: Class 2
Regulation: 21 CFR 866.3361
Advisory panel: Microbiology
Date received: 2013-03-26
Decision date: 2013-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

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