VIDAS CA 15-3 ASSAY


Device Classification Name

test, epithelial ovarian tumor-associated antigen (ca125)

510(k) Number K080469
Device Name VIDAS CA 15-3 ASSAY
Applicant
BIOMERIEUX, INC.
595 anglum rd.
hazelwood, 
MO 
63042

Applicant Contact nikita s mapp
Correspondent
BIOMERIEUX, INC.
595 anglum rd.
hazelwood, 
MO 
63042

Correspodent Contact nikita s mapp
Regulation Number 866.6010
Classification Product Code
LTK  
Date Received 02/21/2008
Decision Date 06/22/2009
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