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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 K151502
Device Name ARCHITECT ROMA
Applicant
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.,
Malvern,  PA  19355
Applicant Contact Diana Dickson
Correspondent
Fujirebio Diagnostics,Inc.
201 Great Valley Pkwy.,
Malvern,  PA  19355
Correspondent Contact Diana Dickson
Regulation Number866.6050
Classification Product Code
ONX  
Date Received06/04/2015
Decision Date 04/28/2016
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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