K-number	K240636
Device name	HemoScreen Hematology Analyzer
Applicant	Pixcell Medical Technologies
Product code	GKZ
Device class	Class II
Decision date	May 2, 2024
Decision	Substantially Equivalent
Regulation	864.5220

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Source

View the full FDA submission: accessdata.fda.gov

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HemoScreen Hematology Analyzer

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