UROVYSION BLADDER CANCER KIT
FDA premarket approval P030052/S012 · decided 2014-01-24
Approval details
- PMA number
- P030052
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2013-08-29
- Decision date
- 2014-01-24
- Days to decision
- 148 days
- Decision code
- APPR
- Product code
- NSD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT LEICA BIOSYSTEMS IN SOLON MILLS, ILLINOIS.
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