PMA P030052S023
- Device
- UroVysion Bladder Cancer Kit
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S023
- Product code
- NAH
- Decision date
- 2018-07-11
- Classification
- System, Test, Tumor Marker, For Detection Of Bladder Cancer
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Approval order statement
- Manufacturing process scale ranges.
Current openFDA PMA Record#
- Device
- UroVysion Bladder Cancer Kit
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S023
- Product code
- NAH
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Decision date
- 2018-07-11
- Decision code
- OK30
- Date received
- 2018-06-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing process scale ranges.