UroVysion Bladder Cancer Kit
FDA premarket approval P030052/S021 · decided 2017-12-06
Approval details
- PMA number
- P030052
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UroVysion Bladder Cancer Kit
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Applicant
- Abbott Molecular
- Date received
- 2017-11-08
- Decision date
- 2017-12-06
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NAH
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- Vendors relocation of a manufacturing site for production of reagents contained in kit components.
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