K-number	K142677
Device name	MALDI Biotyper CA System
Applicant	Bruker Daltonics, Inc.
Product code	PEX
Device class	Class II
Decision date	Mar 27, 2015
Decision	Substantially Equivalent
Regulation	866.3361

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View the full FDA submission: accessdata.fda.gov

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MALDI Biotyper CA System

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