K-number	K160429
Device name	BC-5390 Auto Hematology Analyzer
Applicant	Mindray Bio-Medical Electronics Co., Ltd.
Product code	GKZ
Device class	Class II
Decision date	Sep 1, 2016
Decision	Substantially Equivalent
Regulation	864.5220

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View the full FDA submission: accessdata.fda.gov

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BC-5390 Auto Hematology Analyzer

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