K-number	K080194
Device name	VIDAS CEA (S) ASSAY
Applicant	bioMerieux, Inc.
Product code	DHX
Device class	Class II
Decision date	Oct 9, 2008
Decision	Substantially Equivalent
Regulation	866.6010

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View the full FDA submission: accessdata.fda.gov

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VIDAS CEA (S) ASSAY

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