MALDI Biotyper CA System— 510(k) K142677

Substantially Equivalent

Bruker Daltonics, Inc.

FDA 510(k) clearance K142677 for MALDI Biotyper CA System, Substantially Equivalent on 2015-03-27. Applicant: Bruker Daltonics, Inc..

Clearance details

Applicant: Bruker Daltonics, Inc.
Product code: Code PEX
Advisory panel: Microbiology
Date received: 2014-09-19
Decision date: 2015-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, US

Download summary PDF View on FDA.gov ↗

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