K-number	K012357
Device name	CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM
Applicant	Bayer Diagnostics Corp.
Product code	MOI
Device class	Class II
Decision date	Feb 28, 2002
Decision	Substantially Equivalent
Regulation	866.6010

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View the full FDA submission: accessdata.fda.gov

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CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM

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