PMA P990055S018
- Device
- Atellica IM Complexed PSA (cPSA) Assay
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S018
- Product code
- NAF
- Decision date
- 2019-03-08
- Classification
- Antigen(complexed),prostate Specific,(cpsa)
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Approval order statement
- Adding an additional manufacturing site for the instrument module.
Current openFDA PMA Record#
- Device
- Atellica IM Complexed PSA (cPSA) Assay
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S018
- Product code
- NAF
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Decision date
- 2019-03-08
- Decision code
- OK30
- Date received
- 2019-02-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding an additional manufacturing site for the instrument module.