ROMA (HE4 EIA + ARCHITECT CA 125 II)


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 -1307

Applicant Contact diana l dickson
Correspondent
FUJIREBIO DIAGNOSTICS, INC.
201 great valley pkwy.
malvern, 
PA 
19355 -1307

Correspodent Contact diana l dickson
Regulation Number 866.6050
Classification Product Code
ONX  
Date Received 11/16/2010
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