- Device
- IMMULITE 2000 Free PSA
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- PMA number
- P060005
- Supplement
- S024
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2026-04-21
- Decision code
- APPR
- Date received
- 2025-09-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of the instrument manufacturing site change for the IMMULITE 2000XPi analyzer to the Siemens Healthcare Diagnostics instrument manufacturing facility located in Llanberis, Wales