K-number	DEN090004
Device name	OVA1 TEST
Applicant	Vermillion
Product code	ONX
Device class	Class II
Decision date	Sep 11, 2009
Decision	Not Substantially Equivalent
Regulation	866.6050

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Source

View the full FDA submission: accessdata.fda.gov

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OVA1 TEST

Everything you need for a 510(k) submission. Nothing you don't.