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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name ovarian adnexal mass assessment score test system
De Novo Number DEN090004
510(K) Number K081754
Device Name OVA1 TEST
Requester
VERMILLION
47350 fremont blvd.
fremont,  CA  94538
Contact gillian crutcher
Regulation Number866.6050
Classification Product Code
ONX  
Date Received07/22/2009
Decision Date 09/11/2009
Decision granted (DENG)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Immunology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
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