PMA P200048
- Device
- IsoPSA® Assay
- Applicant
- Cleveland Diagnostics, Inc.
- PMA number
- P200048
- Supplement
- S001
- Product code
- QRF
- Decision date
- 2026-07-28
- Classification
- Immunology
- Generic name
- Multi-analyte test system with algorithmic analysis for detection of prostate cancer
- Approval order statement
- extension of the shelf-life of the IsoPSA Controls
Current openFDA PMA Record#
- Device
- IsoPSA® Assay
- Applicant
- Cleveland Diagnostics, Inc.
- PMA number
- P200048
- Supplement
- S001
- Product code
- QRF
- Generic name
- Multi-analyte test system with algorithmic analysis for detection of prostate cancer
- Decision date
- 2026-07-28
- Decision code
- APPR
- Date received
- 2026-04-29
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- extension of the shelf-life of the IsoPSA Controls