- Device
- Atellica IM Prostate-Specific Antigen (PSA) Assay
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P950021
- Supplement
- S024
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2021-04-27
- Decision code
- OK30
- Date received
- 2021-04-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Moving manufacturing of Atellica IM analyzer’s component/subassembly named Autoloader to an internal supplier.