K-number	K160712
Device name	VITROS Chemistry Products hsCRP Reagent
Applicant	Ortho Clinical Diagnostics
Product code	DCK
Device class	Class II
Decision date	Jul 14, 2017
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 hsCRP Reagent

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