PMA P990055S024
- Device
- Atellica® IM Complexed PSA (cPSA) Assay
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S024
- Decision date
- 2022-03-29
- Approval order statement
- Manufacture an instrument component at another location.
Current openFDA PMA Record#
- Device
- Atellica® IM Complexed PSA (cPSA) Assay
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S024
- Decision date
- 2022-03-29
- Decision code
- OK30
- Date received
- 2022-03-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacture an instrument component at another location.