K-number	K193124
Device name	Unicel DxH 800 Coulter Cellular Analysis System
Applicant	Beckman Coulter
Product code	GKZ
Device class	Class II
Decision date	Apr 16, 2020
Decision	Substantially Equivalent
Regulation	864.5220

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View the full FDA submission: accessdata.fda.gov

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Unicel DxH 800 Coulter Cellular Analysis System

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