K-number	K162020
Device name	VITROS Chemistry Products Cl- Slides
Applicant	Ortho Clinical Diagnostics
Product code	CGZ
Device class	Class II
Decision date	Dec 16, 2016
Decision	Substantially Equivalent
Regulation	862.1170

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS Chemistry Products Cl- Slides

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