K-number	K210346
Device name	Sysmex XW-100 Automated Hematology Analyzer
Applicant	Sysmex America, Inc.
Product code	GKZ
Device class	Class II
Decision date	Nov 8, 2022
Decision	Substantially Equivalent
Regulation	864.5220

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Source

View the full FDA submission: accessdata.fda.gov

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Sysmex XW-100 Automated Hematology Analyzer

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