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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 K103358
Device Name ROMA (HE4 EIA + ARCHITECT CA 125 II)
Applicant
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.
Malvern,  PA  19355
Applicant Contact DIANA L DICKSON
Correspondent
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.
Malvern,  PA  19355
Correspondent Contact DIANA L DICKSON
Regulation Number866.6050
Classification Product Code
ONX  
Date Received11/16/2010
Decision Date 09/01/2011
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT00987649
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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