VIDAS CEA (S) ASSAY


Device Classification Name

system, test, carcinoembryonic antigen

510(k) Number K080194
Device Name VIDAS CEA (S) 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
DHX  
Date Received 01/25/2008
Decision Date 10/09/2008
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