Device Classification Name |
Immunohistochemistry Antibody Assay, Estrogen Receptor
|
510(k) Number |
K110215 |
Device Name |
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY |
Applicant |
VENTANA MEDICAL SYSTEMS, INC. |
1910 EAST INNOVATION PARK DR. |
TUCSON,
AZ
85755
|
|
Applicant Contact |
ROXANE BONNER |
Correspondent |
VENTANA MEDICAL SYSTEMS, INC. |
1910 EAST INNOVATION PARK DR. |
TUCSON,
AZ
85755
|
|
Correspondent Contact |
ROXANE BONNER |
Regulation Number | 864.1860
|
Classification Product Code |
|
Date Received | 12/29/2010 |
Decision Date | 12/17/2012 |
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
|
Recalls |
CDRH Recalls
|
|
|