- Device
- IMMULITE/IMMULITE 1000/IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 Third Generation PSA
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930027
- Supplement
- S023
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2020-08-18
- Decision code
- OK30
- Date received
- 2020-07-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of redundant annual stability testing.