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| Trade Name | BOND ORACLE HER2 IHC SYSTEM |
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| Classification Name | system, test, her-2/neu, ihc |
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| Applicant | LEICA BIOSYSTEMS |
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| PMA Number | P090015 |
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| Date Received | 07/22/2009 |
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| Decision Date | 04/18/2012 |
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| Product Code | |
| Docket Number | 12M-0390 |
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| Notice Date | 04/25/2012 |
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| Advisory Committee |
Pathology |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
Approval for the bond oracle her2 ihc system. This device is indicated for: bond oracle her2 ihc system is a semi-quantitative immunohistochemical (ihc) assay to determine her2 (human epidermal growth factor receptor 2) oncoprotein status in formalin-fixed, parrafin embedded breast cancer tissue processed for histological evaluation following automated staining on the bond-max slide staining instrument. The bond oracle her2 ihc system is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered. |
| Approval Order |
Approval Order
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