- Device
- IMMULITE® 1000 Free PSA, IMMULITE® 2000 Free PSA
- Applicant
- Siemens Medical Solutions Diagnostics Limited
- PMA number
- P060005
- Supplement
- S015
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2023-08-30
- Decision code
- APPR
- Date received
- 2022-03-21
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the change in labeling to include a limitation regarding interference from the drug STRENSIQ.