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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 K081754
Device Name OVA1 TEST
Original Applicant
47350 fremont blvd.
fremont,  CA  94538
Original Contact gillian crutcher
Regulation Number866.6050
Classification Product Code
Date Received06/20/2008
Decision Date 09/11/2009
Decision de novo petitions granted (AN)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
FOI Item Approval Letter
FDA Review Decision Summary
Type De Novo Petitions Granted
Reviewed by Third Party No
Expedited Review No
Combination Product No