- Device
- Adiva Centaur Complexed PSA (cPSA) Immunoassay and Atellica IM cPSA Immunoassay
- Applicant
- Siemens Healthcare Diagnostics
- PMA number
- P990055
- Supplement
- S019
- Product code
- NAF
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Decision date
- 2020-07-02
- Decision code
- APPR
- Date received
- 2019-09-19
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the implementation of a new model luminometer utilized in the in-process testing of Lite Reagent components.