Name: Predicase
Price: 199 USD

K-number	K152433
Device name	VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7
Applicant	Ortho Clinical Diagnostics
Product code	DCK
Device class	Class II
Decision date	Sep 24, 2015
Decision	Substantially Equivalent
Regulation	866.5270

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7

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