URO VYSION BLADDER CANCER KIT ASSAY
FDA premarket approval P030052/S008 · decided 2011-07-20
Approval details
- PMA number
- P030052
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Trade name
- URO VYSION BLADDER CANCER KIT ASSAY
- Generic name
- Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
- Applicant
- Abbott Molecular
- Date received
- 2011-06-23
- Decision date
- 2011-07-20
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NSD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- IMPLEMENTATION OF AN IN-PROCESS VALIDATED TEST METHOD FOR RESTRICTION ENZYME DIGEST GEL ELECTROPHORESIS (DNA RESTRICTION ANALYSIS), CHANGE IN DIGEST RESTRICTION ENZYMES USED IN THE IN-PROCESS TEST, IMPLEMENTATION OF AN IN-PROCESS VALIDATED TEST METHOD FOR DNA CONCENTRATION DETERMINATION BY UV/VIS ABSORBANCE SPECTROPHOTOMETRY, AND ADDITION OF AN INCOMING SCREENING TEST FOR DEXTRAN SULFATE.
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