Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name ovarian adnexal mass assessment score test system
510(K) Number K081754
Device Name OVA1 TEST
Applicant
VERMILLION
47350 fremont blvd.
fremont,  CA  94538
Contact gillian crutcher
Regulation Number866.6050
Classification Product Code
ONX  
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
-
-