OVA1 TEST

Ovarian Adnexal Mass Assessment Score Test System

VERMILLION

The following data is part of a De Novo classification by Vermillion with the FDA for Ova1 Test.

Pre-market Notification Details

• DeNovo ID: DEN090004
• Device Name: OVA1 TEST
• Classification: Ovarian Adnexal Mass Assessment Score Test System
• Applicant: VERMILLION 47350 Fremont Blvd. Fremont, CA 94538
• Contact: Gillian Crutcher
• Product Code: ONX
• CFR Regulation Number: 866.6050 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: K081754
• Review Advisory Board: Immunology
• Classification Advisory: Obstetrics/Gynecology
• Type: Post-NSE
• Date Received: 2009-07-22
• Decision Date: 2009-09-11
• FDA Review: Decision Summary
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860942000113	DEN090004	000