PMA P030052S012
- Device
- UROVYSION BLADDER CANCER KIT
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S012
- Product code
- NSD
- Decision date
- 2014-01-24
- 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 A MANUFACTURING SITE LOCATED AT LEICA BIOSYSTEMS IN SOLON MILLS, ILLINOIS.
Current openFDA PMA Record#
- Device
- UROVYSION BLADDER CANCER KIT
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S012
- Product code
- NSD
- Generic name
- Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
- Decision date
- 2014-01-24
- Decision code
- APPR
- Date received
- 2013-08-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT LEICA BIOSYSTEMS IN SOLON MILLS, ILLINOIS.