UroVysion Bladder Cancer Kit
FDA premarket approval P030052/S026 · decided 2019-08-26
Approval details
- PMA number
- P030052
- Supplement
- S026
- 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
- 2019-07-31
- Decision date
- 2019-08-26
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- NAH
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- Update to software.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| simpli-COLLECT STI Test (K243410) | Abbott Molecular | 2025-01-30 |
| Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) (K241580) | Abbott Molecular | 2024-12-06 |