Name: Predicase
Price: 199 USD

K-number	K031607
Device name	ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL
Applicant	Orion Diagnostica, Div. Orion Corp.
Product code	DCK
Device class	Class II
Decision date	Oct 10, 2003
Decision	Substantially Equivalent
Regulation	866.5270

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Source

View the full FDA submission: accessdata.fda.gov

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ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL

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