Name: Predicase
Price: 199 USD

K-number	K231290
Device name	Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
Applicant	The Binding Site, Ltd.
Product code	DFH
Device class	Class II
Decision date	Jan 24, 2024
Decision	Substantially Equivalent
Regulation	866.5550

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Source

View the full FDA submission: accessdata.fda.gov

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Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit

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