VIDAS AFP ASSAY


Device Classification Name

kit, test,alpha-fetoprotein for testicular cancer

510(k) Number K080017
Device Name VIDAS AFP 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
LOJ  
Date Received 01/03/2008
Decision Date 09/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No