K-number	K231525
Device name	VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
Applicant	Ortho Clinical Diagnostics
Product code	NIG
Device class	Class II
Decision date	Aug 9, 2023
Decision	Substantially Equivalent
Regulation	866.6010

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Source

View the full FDA submission: accessdata.fda.gov

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VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack

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