PMA P030052S014
- Device
- UROVYSION BLADDER CANCER KIT
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S014
- Product code
- NSD
- Decision date
- 2013-12-20
- 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
- CHANGE TO THE FERMENTATION STAGE OF THE UROVYSION AND PATHVYSION ASSAY MANUFACTURING PROCESSES.
Current openFDA PMA Record#
- Device
- UROVYSION BLADDER CANCER KIT
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S014
- Product code
- NSD
- Generic name
- Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
- Decision date
- 2013-12-20
- Decision code
- OK30
- Date received
- 2013-11-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE FERMENTATION STAGE OF THE UROVYSION AND PATHVYSION ASSAY MANUFACTURING PROCESSES.