Device Classification Name |
microscope, automated, image analysis, immunohistochemistry,operator intervention,nuclear intensity & percent positivity
|
510(k) Number |
K111869 |
Device Name |
VIRTUOSO SYSTEM FOR IHC PR (IE2) |
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
|
|
Correspondent Contact |
TROY QUANDER |
Regulation Number | 864.1860
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/01/2011 |
Decision Date | 03/05/2012 |
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
|
|
|