K-number	K172604
Device name	XW-100 Automated Hematology Analyzer for CLIA Waived Use
Applicant	Sysmex America, Inc.
Product code	GKZ
Device class	Class II
Decision date	Nov 6, 2017
Decision	Substantially Equivalent
Regulation	864.5220

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Source

View the full FDA submission: accessdata.fda.gov

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XW-100 Automated Hematology Analyzer for CLIA Waived Use

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