Name: Predicase
Price: 199 USD

K-number	K142993
Device name	QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
Applicant	Orion Diagnostica, OY
Product code	DCK
Device class	Class II
Decision date	Mar 10, 2016
Decision	Substantially Equivalent
Regulation	866.5270

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Source

View the full FDA submission: accessdata.fda.gov

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QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument

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