DAKO HERCEPTEST
FDA premarket approval P980018 · decided 1998-09-25
Approval details
- PMA number
- P980018
- Trade name
- DAKO HERCEPTEST
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- Date received
- 1998-05-18
- Decision date
- 1998-09-25
- Days to decision
- 130 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- 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.
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