HER2 CISH PHARMDX KIT
FDA premarket approval P100024/S010 · decided 2016-09-27
Approval details
- PMA number
- P100024
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HER2 CISH PHARMDX KIT
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Applicant
- Dako Denmark A/S
- Date received
- 2016-07-01
- Decision date
- 2016-09-27
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- NYQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Glostrup
- Statement
- Approval for the DakoLink software version 4.1 update for the HER2 CISH pharmDx Kit
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| FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) (K170028) | Dako Denmark A/S | 2017-12-21 |
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