HE4 EIA, MODEL: 404-10 US


Device Classification Name

test, epithelial ovarian tumor associated antigen (he4)

510(k) Number K072939
Device Name HE4 EIA, MODEL: 404-10 US
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 866.6010
Classification Product Code
OIU  
Date Received 10/17/2007
Decision Date 06/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No