PMA P990055S017
- Device
- Atellica IM Complexed PSA (cPSA)
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S017
- Product code
- NAF
- Decision date
- 2018-10-25
- Classification
- Antigen(complexed),prostate Specific,(cpsa)
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Approval order statement
- Approval for the placement of the PMA approved Siemens Atellica® IM Immunology assays on the Atellica Solution.
Current openFDA PMA Record#
- Device
- Atellica IM Complexed PSA (cPSA)
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S017
- Product code
- NAF
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Decision date
- 2018-10-25
- Decision code
- APPR
- Date received
- 2018-07-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the placement of the PMA approved Siemens Atellica® IM Immunology assays on the Atellica Solution.