PMA P050045S004
- Device
- TOP2A FISH PHARMADX KIT
- Applicant
- Dako Denmark A/S
- PMA number
- P050045
- Supplement
- S004
- Product code
- NXG
- Decision date
- 2012-06-01
- Generic name
- Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
- Approval order statement
- APPROVAL FOR THE MANUFACTURING PROCESS OF PMA OLIGOMERS IN THE DEVICE.
Current openFDA PMA Record#
- Device
- TOP2A FISH PHARMADX KIT
- Applicant
- Dako Denmark A/S
- PMA number
- P050045
- Supplement
- S004
- Product code
- NXG
- Generic name
- Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
- Decision date
- 2012-06-01
- Decision code
- APPR
- Date received
- 2011-12-23
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE MANUFACTURING PROCESS OF PMA OLIGOMERS IN THE DEVICE.