HER2 CISH PHARMADX KIT
FDA premarket approval P100024/S001 · decided 2012-02-01
Approval details
- PMA number
- P100024
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HER2 CISH PHARMADX KIT
- Generic name
- Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
- Applicant
- Dako Denmark A/S
- Date received
- 2011-12-07
- Decision date
- 2012-02-01
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- NYQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Glostrup
- Statement
- APPROVAL FOR AN UPDATE OF THE SOFTWARE DOCUMENTATION FOR DAKOLINK SOFTWARE VERSION 3.0 TO DAKOLINK VERSION 3.1.1.
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