K-number	K192916
Device name	NOVA Lite DAPI dsDNA Crithidia luciliae Kit
Applicant	Inova Diagnostics, Inc.
Product code	KTL
Device class	Class II
Decision date	Dec 11, 2020
Decision	Substantially Equivalent
Regulation	866.5100

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Source

View the full FDA submission: accessdata.fda.gov

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NOVA Lite DAPI dsDNA Crithidia luciliae Kit

Everything you need for a 510(k) submission. Nothing you don't.