TOP2A FISH PHARMDX KIT
FDA premarket approval P050045/S001 · decided 2008-02-13
Approval details
- PMA number
- P050045
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TOP2A FISH PHARMDX KIT
- Generic name
- Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
- Applicant
- Dako Denmark A/S
- Date received
- 2008-01-28
- Decision date
- 2008-02-13
- Days to decision
- 16 days
- Decision code
- APPR
- Product code
- NXG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Glostrup
- Statement
- APPROVAL FOR MODIFICATION OF THE CEN 17 REFERENCE PNA PROBES AND ADJUSTMENT OF THE CONCENTRATION OF THE TOP2A GENE TARGETED DNA PROBES IN VIAL 3 PROBE MIX.
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