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Device | PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY |
Generic Name | system, test, her-2/neu, ihc |
Applicant |
VENTANA MEDICAL SYSTEMS, INC. |
1910 e. innovation park dr. |
tucson, AZ 85755 |
|
PMA Number | P990081 |
Date Received | 12/13/1999 |
Decision Date | 11/28/2000 |
Product Code |
MVC
|
Docket Number | 00M-1661 |
Notice Date | 12/12/2000 |
Advisory Committee |
Pathology |
Expedited Review Granted? | No |
Combination Product |
No
|
Recalls |
CDRH Recalls
|
Approval Order Statement
APPROVAL FOR THE PATHWAY(TM) HER 2 (CLONE CB11). THE DEVICE IS A MOUSE MONOCLONAL ANTIBODY INTENDED FOR LABORATORY USE FOR THE SEMI-QUANTITATIVE DETECTION OF C-ERBB-2 ANTIGEN IN SECTIONS OF FORMALIN FIXED, PARAFFIN EMBEDDED NORMAL AND NEOPLASTIC TISSUE ON A VENTANA AUTOMATED IMMUNOHISTOCHEMISTRY SLIDE STAINING DEVICE. IT IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST CANCER PATIENTS FOR WHOM HERCEPTIN(R) TREATMENT IS BEING CONSIDERED. |
Approval Order |
Approval Order
|
Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
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Supplements: |
S007 S006 S004 S016 S033 S024 S032 S031 S023 S022 S018 S026 S025 S013 S021 S035 S005 S008 S002 S003 S001 S034 S030 S029 S028 S015 S020 S019 S014 S027 S012 S017 S010 S011 S040 S036 S039 S041 S042 S043 S038 |