K-number	K052000
Device name	ARCHITECT CA 19-9XR ASSAY
Applicant	Fujirebio Diagnostics,Inc.
Product code	NIG
Device class	Class II
Decision date	Oct 25, 2005
Decision	Substantially Equivalent
Regulation	866.6010

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View the full FDA submission: accessdata.fda.gov

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ARCHITECT CA 19-9XR ASSAY

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