K-number	K990984
Device name	VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS
Applicant	Ortho-Clinical Diagnostics, Inc.
Product code	JJX
Device class	Class I
Decision date	Apr 8, 1999
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS

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