- Device
- Dimension Vista FPSA Flex reagent cartridge
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P020027
- Supplement
- S037
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2021-10-08
- Decision code
- APPR
- Date received
- 2020-06-01
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change in the manufacturing process of streptavidin.