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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ovarian Adnexal Mass Assessment Score Test System
510(k) Number K150588
Device Name OVA1 Next Generation
Applicant
Vermillion, Inc.
12117 Bee Caves Rd., Bldg. Iii, Suite 100
Austin,  TX  78738
Applicant Contact Benjamin A Kimball
Correspondent
Vermillion, Inc.
12117 Bee Caves Rd., Bldg. Iii, Suite 100
Austin,  TX  78738
Correspondent Contact Benjamin A Kimball
Regulation Number866.6050
Classification Product Code
ONX  
Date Received03/09/2015
Decision Date 03/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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