PMA P990055S028
- Device
- Atellica IM Complexed PSA (cPSA)
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S028
- Product code
- NAF
- Decision date
- 2024-09-23
- Classification
- Immunology
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Approval order statement
- placement of Atellica IM assay onto the Atellica CI Analyzer with Atellica Sample Handler configuration.
Current openFDA PMA Record#
- Device
- Atellica IM Complexed PSA (cPSA)
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S028
- Product code
- NAF
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Decision date
- 2024-09-23
- Decision code
- APPR
- Date received
- 2024-06-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- placement of Atellica IM assay onto the Atellica CI Analyzer with Atellica Sample Handler configuration.