Device Classification Name |
Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
|
510(k) Number |
K130515 |
Device Name |
VIRTUOSO SYSTEM FOR IHC ER (SPI) |
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 | 02/27/2013 |
Decision Date | 11/22/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Pathology
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|