K-number	K180971
Device name	QUANTA Flash Calprotectin and Fecal Extraction Device
Applicant	Inova Diagnostics, Inc.
Product code	NXO
Device class	Class II
Decision date	Oct 16, 2018
Decision	Substantially Equivalent
Regulation	866.5180

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Source

View the full FDA submission: accessdata.fda.gov

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QUANTA Flash Calprotectin and Fecal Extraction Device

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