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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: |
S035 S010 S021 S022 S015 S001 S006 S004 S025 S016 S012 S013 S017 S018 S019 S020 S026 S027 S028 S029 S011 S002 S008 S005 S003 S032 S033 S031 S030 S034 S014 S050 S047 S048 S023 S024 S007 S036 S038 S039 S040 S041 S042 S043 S044 S045 S046
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