- Device
- Dimension® FPSA Flex® reagent cartridge
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P020027
- Supplement
- S039
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2021-12-20
- Decision code
- OK30
- Date received
- 2021-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an Alternate Supplier for the Lens and Mirror components used in Photometer Assembly on the Dimension Family of Instruments.