PMA P020027S042
- Device
- Dimension FPSA Flex reagent cartridge
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P020027
- Supplement
- S042
- Product code
- MTF
- Decision date
- 2025-05-22
- Classification
- Immunology
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- Transfer of Service Spare Parts Production to Contract Manufacturer.
Current openFDA PMA Record#
- Device
- Dimension FPSA Flex reagent cartridge
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P020027
- Supplement
- S042
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2025-05-22
- Decision code
- OK30
- Date received
- 2025-04-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of Service Spare Parts Production to Contract Manufacturer.