K-number	K201256
Device name	Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
Applicant	Procise Diagnostics
Product code	DCK
Device class	Class II
Decision date	Nov 4, 2022
Decision	Substantially Equivalent
Regulation	866.5270

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Source

View the full FDA submission: accessdata.fda.gov

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Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge

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