PMA P190022
- Device
- 4Kscore Test
- Applicant
- Opko Health, Inc.
- PMA number
- P190022
- Product code
- QRF
- Decision date
- 2025-07-25
- Generic name
- Multi-analyte test system with algorithmic analysis for detection of prostate cancer
- Approval order statement
- Approval for the addition of the DRE Unavailable variant as part of the 4KScore Test system
Current openFDA PMA Record#
- Device
- 4Kscore Test
- Applicant
- Opko Health, Inc.
- PMA number
- P190022
- Supplement
- S003
- Product code
- QRF
- Generic name
- Multi-analyte test system with algorithmic analysis for detection of prostate cancer
- Decision date
- 2025-07-25
- Decision code
- APPR
- Date received
- 2025-01-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of the DRE Unavailable variant as part of the 4KScore Test system