K-number	K161982
Device name	C-Reactive Protein Kit for use on SPAPLUS
Applicant	The Binding Site Group
Product code	DCN
Device class	Class II
Decision date	Apr 5, 2017
Decision	Substantially Equivalent
Regulation	866.5270

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Source

View the full FDA submission: accessdata.fda.gov

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C-Reactive Protein Kit for use on SPAPLUS

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