UROVYSION BLADDER CANCER KIT
FDA premarket approval P030052/S002 · decided 2007-02-06
Approval details
- PMA number
- P030052
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UROVYSION BLADDER CANCER KIT
- Generic name
- Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
- Applicant
- Abbott Molecular
- Date received
- 2007-01-08
- Decision date
- 2007-02-06
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NSD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- 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.
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