TOP2A FISH PHARMDX
FDA premarket approval P050045/S002 · decided 2008-03-26
Approval details
- PMA number
- P050045
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TOP2A FISH PHARMDX
- Generic name
- Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
- Applicant
- Dako Denmark A/S
- Date received
- 2008-03-06
- Decision date
- 2008-03-26
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- NXG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Glostrup
- Statement
- CHANGE IN AUXILIARY MATERIAL/SUPPLIER USED IN THE PRODUCTION OF THE PROBE MIX TO ELIMINATE ENZYME RELATED STABILITY PROBLEMS.
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