UroVysion Bladder Cancer Kit
FDA premarket approval P030052/S029 · decided 2025-01-29
Approval details
- PMA number
- P030052
- Supplement
- S029
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UroVysion Bladder Cancer Kit
- Applicant
- Abbott Molecular
- Date received
- 2025-01-08
- Decision date
- 2025-01-29
- Days to decision
- 21 days
- Decision code
- OK30
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- implementation of a new, functionally equivalent normal cell line to manufacture control slides used with the UroVysion Bladder Cancer Kit
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 |