Name: Predicase
Price: 199 USD

K-number	K022176
Device name	ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257
Applicant	Orion Diagnostica, Div. Orion Corp.
Product code	DCK
Device class	Class II
Decision date	Dec 3, 2002
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 ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257

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