HER2 CISH PHARMDX KIT
FDA premarket approval P100024/S003 · decided 2012-11-27
Approval details
- PMA number
- P100024
- Supplement
- S003
- 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
- 2012-09-20
- Decision date
- 2012-11-27
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- NYQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Glostrup
- Statement
- APPROVAL FOR A CHANGE IN THE MOUNTING MEDIUM REAGENT SUPPLIED IN THE KIT.
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