- Device
- Elecsys total PSA, total PSA CalSet II
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P990056
- Supplement
- S039
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2023-03-23
- Decision code
- APPR
- Date received
- 2022-09-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to extend application of the Elecsys total PSA immunoassay onto the cobas e 402 immunoassay analyzer