- Device
- Atellica IM Prostate-Specific Antigen (PSA)
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S029
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2024-09-23
- Decision code
- APPR
- Date received
- 2024-06-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- placement of Atellica IM assay onto the Atellica CI Analyzer with Atellica Sample Handler configuration.