- Device
- Elecsys total PSA Test System
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P990056
- Supplement
- S038
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2021-11-16
- Decision code
- OK30
- Date received
- 2021-10-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expansion of manufacturing activities for the production of lyophilized calibrators to an additional building within the same manufacturing site.