K-number	K101809
Device name	FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20
Applicant	Fujirebio Diagnostics,Inc.
Product code	JJY
Device class	Class I
Decision date	Oct 5, 2010
Decision	Substantially Equivalent
Regulation	862.1660

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View the full FDA submission: accessdata.fda.gov

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FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20

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