Device Classification Name |
Microscope, Automated, Image Analysis, Operator Intervention
|
510(k) Number |
K121033 |
Device Name |
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) |
Applicant |
VENTANA MEDICAL SYSTEMS, INC. |
575 Shirlynn Court |
Los Altos,
CA
94022
|
|
Applicant Contact |
ERIKA AMMIRATI |
Correspondent |
VENTANA MEDICAL SYSTEMS, INC. |
575 Shirlynn Court |
Los Altos,
CA
94022
|
|
Correspondent Contact |
ERIKA AMMIRATI |
Regulation Number | 864.1860
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/05/2012 |
Decision Date | 09/06/2013 |
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
|
|
|