K-number	K143577
Device name	XW-100 Automated Hematology Analyzer, XW QC CHECK
Applicant	Sysmex America, Inc.
Product code	GKZ
Device class	Class II
Decision date	Oct 12, 2015
Decision	Substantially Equivalent
Regulation	864.5220

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View the full FDA submission: accessdata.fda.gov

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XW-100 Automated Hematology Analyzer, XW QC CHECK

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