TOP2A FISH PHARMADX KIT
FDA premarket approval P050045/S004 · decided 2012-06-01
Approval details
- PMA number
- P050045
- Supplement
- S004
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TOP2A FISH PHARMADX KIT
- Generic name
- Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
- Applicant
- Dako Denmark A/S
- Date received
- 2011-12-23
- Decision date
- 2012-06-01
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- NXG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Glostrup
- Statement
- APPROVAL FOR THE MANUFACTURING PROCESS OF PMA OLIGOMERS IN THE DEVICE.
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