PMA P030052S020
- Device
- Urovysion Bladder Cancer Kit
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S020
- Product code
- NSD
- Decision date
- 2017-04-12
- Classification
- Test, Fluorescence In Situ Hybridization (fish), For Bladder Cancer Detection And Monitoring For Recurrence
- Generic name
- Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
- Approval order statement
- Approval for upgrades to the VP 2000 Processor.
Current openFDA PMA Record#
- Device
- Urovysion Bladder Cancer Kit
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S020
- Product code
- NSD
- Generic name
- Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
- Decision date
- 2017-04-12
- Decision code
- APPR
- Date received
- 2016-11-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for upgrades to the VP 2000 Processor.