FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL


Device Classification Name

test, epithelial ovarian tumor associated antigen (he4)

510(k) Number K103676
Device Name FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL
Applicant
FUJIREBIO DIAGNOSTICS, INC.
201 great valley pkwy.
malvern, 
PA 
19355 -1307

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

Correspodent Contact diana lyn dickson
Regulation Number 866.6010
Classification Product Code
OIU  
Subsequent Product Code
JJY  
Date Received 12/16/2010
Decision Date 07/19/2011
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