K-number	K131140
Device name	OMNYX IDP FOR HER2 MANUAL APPLICATION
Applicant	Omnyx, LLC
Product code	OEO
Device class	Class II
Decision date	Apr 1, 2014
Decision	Substantially Equivalent
Regulation	864.1860

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Source

View the full FDA submission: accessdata.fda.gov

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OMNYX IDP FOR HER2 MANUAL APPLICATION

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