K-number	DEN120008
Device name	STRATIFY JCV(TM) ANTIBODY
Applicant	Focus Diagnostics, Inc.
Product code	OYP
Device class	Class II
Decision date	Jan 20, 2012
Decision	Not Substantially Equivalent
Regulation	866.3336

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View the full FDA submission: accessdata.fda.gov

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STRATIFY JCV(TM) ANTIBODY

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