VIRTUOSO SYSTEM FOR IHC P53 (DO-7)


Device Classification Name

microscope,automated,image analysis,immunohistochemistry,operator intervention,nuclear intensity & percent positivity

510(k) Number K111872
Device Name VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
Applicant
VENTANA MEDICAL SYSTEMS, INC.
1910 east innovation park dr.
tucson, 
AZ 
85755

Applicant Contact troy quander
Correspondent
VENTANA MEDICAL SYSTEMS, INC.
1910 east innovation park dr.
tucson, 
AZ 
85755

Correspodent Contact troy quander
Regulation Number 864.1860
Classification Product Code
NQN  
Subsequent Product Codes
NOT   OEO  
Date Received 07/01/2011
Decision Date 04/19/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Pathology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No