K-number	K042731
Device name	ARCHITECT CA 125 II ASSAY
Applicant	Fujirebio Diagnostics,Inc.
Product code	LTK
Device class	Class II
Decision date	Nov 19, 2004
Decision	Substantially Equivalent
Regulation	866.6010

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Source

View the full FDA submission: accessdata.fda.gov

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ARCHITECT CA 125 II ASSAY

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