PMA P030052S025
- Device
- UroVysion Bladder Cancer Kit
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S025
- Product code
- NSD
- Decision date
- 2019-05-08
- Classification
- Fluorescence In Situ Hybridization, Chromosome 17p Deletion (tp53)
- Generic name
- Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
- Approval order statement
- Change to a critical reagent suppliers location.
Current openFDA PMA Record#
- Device
- UroVysion Bladder Cancer Kit
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S025
- Product code
- NSD
- Generic name
- Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
- Decision date
- 2019-05-08
- Decision code
- OK30
- Date received
- 2019-04-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to a critical reagent suppliers location.