K-number	DEN180017
Device name	Quantra Hemostasis Analyzer, QPlus Cartridge
Applicant	Hemosonics, LLC
Product code	QFR
Device class	Class II
Decision date	Mar 12, 2019
Decision	Not Substantially Equivalent
Regulation	864.5430

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View the full FDA submission: accessdata.fda.gov

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Quantra Hemostasis Analyzer, QPlus Cartridge

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