- Device
- Dimension® TPSA Flex® reagent cartridge
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P000021
- Supplement
- S044
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- 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.