PMA P030052S002
- Device
- UROVYSION BLADDER CANCER KIT
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S002
- Product code
- NSD
- Decision date
- 2007-02-06
- 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 THE ADDITION OF THE THERMOBRITE AUTOMATED SLIDE HEATING PLATE SUPPLIED BY AN ALTERNATE VENDOR AS AN OPTIONAL ALTERNATIVE OF THE HYBRITE AUTOMATED SLIDE HEATING PLATE INSTRUMENT AND TO ADD INSTRUCTIONS FOR USE OF SAID THERMOBRITE TO THE CURRENT UROVYSION BLADDER CANCER KIT PACKAGE INSERT.
Current openFDA PMA Record#
- Device
- UROVYSION BLADDER CANCER KIT
- Applicant
- Abbott Molecular
- PMA number
- P030052
- Supplement
- S002
- Product code
- NSD
- Generic name
- Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
- Decision date
- 2007-02-06
- Decision code
- APPR
- Date received
- 2007-01-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE THERMOBRITE AUTOMATED SLIDE HEATING PLATE SUPPLIED BY AN ALTERNATE VENDOR AS AN OPTIONAL ALTERNATIVE OF THE HYBRITE AUTOMATED SLIDE HEATING PLATE INSTRUMENT AND TO ADD INSTRUCTIONS FOR USE OF SAID THERMOBRITE TO THE CURRENT UROVYSION BLADDER CANCER KIT PACKAGE INSERT.