K-number	K171655
Device name	cobas m 511 integrated hematology analyzer
Applicant	Roche Diagnostics Hematology, Inc.
Product code	GKZ
Device class	Class II
Decision date	Mar 2, 2018
Decision	Substantially Equivalent
Regulation	864.5220

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Source

View the full FDA submission: accessdata.fda.gov

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cobas m 511 integrated hematology analyzer

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