K-number	K191635
Device name	Optilite IgM Kit
Applicant	The Binding Site Group , Ltd.
Product code	CFN
Device class	Class II
Decision date	Jul 15, 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 IgM Kit

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