PMA P990055S025
- Device
- Atellica IM complexed PSA (cPSA)
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S025
- Product code
- NAF
- Decision date
- 2024-02-13
- Classification
- Immunology
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Approval order statement
- Migration of the Siemens ADVIA Centaur cPSA assay to the Atellica CI analyzer.
Current openFDA PMA Record#
- Device
- Atellica IM complexed PSA (cPSA)
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S025
- Product code
- NAF
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Decision date
- 2024-02-13
- Decision code
- APPR
- Date received
- 2023-08-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Migration of the Siemens ADVIA Centaur cPSA assay to the Atellica CI analyzer.