The 4Kscore Test
FDA premarket approval P190022/S002 · decided 2024-01-30
Approval details
- PMA number
- P190022
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- The 4Kscore Test
- Generic name
- Multi-analyte test system with algorithmic analysis for detection of prostate cancer
- Applicant
- Opko Health, Inc.
- Date received
- 2023-11-01
- Decision date
- 2024-01-30
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- QRF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Miami, FL
- Statement
- Approval for software changes made to the B2 Laboratory Information System (LIS) and Specimen Processing Module (SPM) of the 4Kscore Test.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SPECTRAL OCT/SLO (K080460) | Opko Health, Inc. | 2008-11-14 |