K-number	K183151
Device name	Optilite IgA CSF Kit
Applicant	The Binding Site Group , Ltd.
Product code	CFN
Device class	Class II
Decision date	Jan 23, 2019
Decision	Substantially Equivalent
Regulation	866.5510

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Source

View the full FDA submission: accessdata.fda.gov

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Optilite IgA CSF Kit

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