Name: Predicase
Price: 199 USD

K-number	K172868
Device name	Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
Applicant	The Binding Site Group , Ltd.
Product code	DCN
Device class	Class II
Decision date	Feb 28, 2018
Decision	Substantially Equivalent
Regulation	866.5270

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Source

View the full FDA submission: accessdata.fda.gov

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Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls

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