PMA P030052S017
- Device
- UROVYSION BLADDER CANCER KIT,PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S017
- Product code
- NSD
- Decision date
- 2015-12-29
- 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 MANUFACTURING PROCESS CHANGES TO COMPONENTS OF THEPROBECHEK CONTROL SLIDES FOR FISH USING UROVYSION BLADDER CANCER KIT.
Current openFDA PMA Record#
- Device
- UROVYSION BLADDER CANCER KIT,PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S017
- Product code
- NSD
- Generic name
- Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
- Decision date
- 2015-12-29
- Decision code
- APPR
- Date received
- 2015-11-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR MANUFACTURING PROCESS CHANGES TO COMPONENTS OF THEPROBECHEK CONTROL SLIDES FOR FISH USING UROVYSION BLADDER CANCER KIT.