| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | DAKO HERCEPTEST |
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| Generic Name | SYSTEM, TEST, HER-2/NEU, IHC |
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| Applicant | Agilent Technologies Singapore (International) Pte Ltd.
No. 1 Yishun Avenue 7
Singapore 76892 |
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| PMA Number | P980018 |
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| Date Received | 05/18/1998 |
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| Decision Date | 09/25/1998 |
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| Product Code |
MVC |
| Docket Number | 98M-0857 |
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| Notice Date | 10/27/1998 |
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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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| Recalls | CDRH Recalls |
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Approval Order Statement
Approval for the DAKO Herceptest. This device is a semi-quantitative immunohistochemical assay to determine HER2 overexpression in breast cancer tissues routinely processed for histological evaluation. HercepTest is indicated as an aid in the assessment of patients for whom HERCEPTIN(R)(Transtuzumab) treatment is being considered. |
| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023
S024 S025 |
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